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PubMed2001

The attributable mortality and length of intensive care unit stay of clinically important gastrointestinal bleeding in critically ill patients.

OBJECTIVE: To estimate the mortality and length of stay in the intensive care unit (ICU) attributable to clinically important gastrointestinal bleeding in mechanically ventilated critically ill patients. DESIGN: Three strategies were used to estimate the mortality attributable to bleeding in two multicentre databases. The first method matched patients who bled with those who did not (matched cohort), using duration of ICU stay prior to the bleed, each of six domains of the Multiple Organ Dysfunction Score (MODS) measured 3 days prior to the bleed, APACHE II score, age, admitting diagnosis, and duration of mechanical ventilation. The second approach employed Cox proportional hazards regression to match bleeding and non-bleeding patients (model-based matched cohort). The third method, instead of matching, derived estimates based on regression modelling using the entire population (regression method). Three parallel analyses were conducted for the length of ICU stay attributable to clinically important bleeding. SETTING: Sixteen Canadian university-affiliated ICUs. PATIENTS: A total of 1666 critically ill patients receiving mechanical ventilation for at least 48 hours. MEASUREMENTS: We prospectively collected data on patient demographics, APACHE II score, admitting diagnosis, daily MODS, clinically important bleeding, length of ICU stay, and mortality. Independent adjudicators determined the occurrence of clinically important gastrointestinal bleeding, defined as overt bleeding in association with haemodynamic compromise or blood transfusion. RESULTS: Of 1666 patients, 59 developed clinically important gastrointestinal bleeding. The mean APACHE II score was 22.9 +/- 8.6 among bleeding patients and 23.3 +/- 7.7 among non-bleeding patients. The risk of death was increased in patients with bleeding using all three analytic approaches (matched cohort method: relative risk [RR]= 2.9, 95% confidence interval (CI)= 1.6-5.5; model-based matched cohort method: RR = 1.8, 95% CI = 1.1-2.9; and the regression method: RR = 4.1, 95% CI = 2.6-6.5). However, this was not significant for the adjusted regression method (RR = 1.0, 95% CI = 0.6-1.7). The median length of ICU stay attributable to clinically important bleeding for these three methods, respectively, was 3.8 days (95% CI = -0.01 to 7.6 days), 6.7 days (95% CI = 2.7-10.7 days), and 7.9 days (95% CI = 1.4-14.4 days). CONCLUSIONS: Clinically important upper gastrointestinal bleeding has an important attributable morbidity and mortality, associated with a RR of death of 1-4 and an excess length of ICU stay of approximately 4-8 days.

APACHE↗

PubMed2002

Local therapeutic injection in bleeding peptic ulcer: a comparison of adrenaline to adrenaline plus a sclerosing agent.

OBJECTIVE: a) To analyse the probability of haemodynamic changes in patients with non-variceal upper gastrointestinal bleeding (NV-UGB), as well as the risk of bleeding in cases of peptic ulcer; and b) to compare an injection of epinephrine alone with epinephrine plus an sclerosing agent in ulcers with a high risk of persistent or recurrent bleeding. METHODS: We studied 500 consecutive patients (295 males/205 females) who were admitted because of an NV-UGB episode. Haemodynamic evaluation and upper endoscopy were performed in all patients. They were randomised to receive an injection of epinephrine 1:10.000 or epinephrine plus 2% polidocanol in case of active bleeding, visible vessel or unstable clot. RESULTS: 263/500 (52.6%) were taking NSAIDs before the acute bleeding. 70/96 (72.9%) patients with red haematemesis showed haemodynamic changes vs 15/107 (14%) with dark haematemesis and melena, and 29/281 (10.3%) with melena alone, p < 0.01, OR = 20. Duodenal ulcer was the cause of NV-UGB in 206 cases (40.6%) and gastric ulcer in 134 (27.2%). However, an endoscopic therapy was performed in 85 patients, 58 with gastric ulcers (19 with active bleeding, 33 with visible vessel and 6 with unstable clot) vs 27 with duodenal ulcers (6 with active bleeding, 19 with visible vessel and 2 with unstable clot), p < 0.01, OR = 4.7. 15/85 patients developed recurrent bleeding after injection therapy: 3 with a non-bleeding visible vessel and 10 with active bleeding (10 were treated with epinephrine and 2 with epinephrine plus 2% polidocanol, p < 0.04, OR = 8). A multivariate logistic regression analysis showed that age, active bleeding and type of injected agent were the only independent variables associated with failure of treatment and recurrent bleeding. CONCLUSIONS: a) 52.6% of patients with NV-UGB were taking NSAIDs before acute bleeding; b) epinephrine injection followed by a sclerosing agent is more effective in case of active bleeding; however, there is no difference in case of visible vessel or unstable clot; and c) age, active bleeding and type of treatment were the only independent variables associated with recurrent bleeding.

Adult↗

PubMed1997

Risk of persistent or recurrent and intractable upper gastrointestinal bleeding in the era of therapeutic endoscopy.

OBJECTIVES: Patients who present to the emergency department with upper gastrointestinal bleeding can have persistent or recurrent (further) bleeding or self-limited bleeding. We performed a study to determine the frequency, risks factors, and impact on outcome of further bleeding. METHODS: Clinical predictors of further bleeding were retrospectively identified in 137 consecutive patients presenting to our institution with upper gastrointestinal bleeding in 1994-1995. RESULTS: Persistent or recurrent bleeding occurred in 30.7% of the cases, bleeding intractable to endoscopic therapy occurred in 15.3%. Hematemesis (odds ratio [OR] 5.7; 95% confidence interval [CI], 2.4-13.1, p = 0.0001) and a initial hemoglobin (OR, 0.8; 95% CI, 0.7-0.96; p = 0.01) were independent risk factors for persistent or recurrent bleeding, whereas liver disease (OR, 6.0; 95% CI, 2.0-18.4; p = 0.002) and hematemesis were independent risk factors for intractable bleeding. The mortality rate was 14.3 and 1%, respectively, in patients with and without further bleeding. In patients who did not present with hematemesis, liver disease, coagulopathy, hypotension, and initial hemoglobin < 11 g/dl, the frequency of further bleeding and mortality was 0%. CONCLUSIONS: Persistent, recurrent, and intractable bleeding occurs in a substantial proportion of patients admitted with upper gastrointestinal bleeding. The risk of further bleeding can be estimated on the basis of clinical presentation. Further bleeding is associated with a worse outcome.

Endoscopy, Gastrointestinal↗

PubMed2005

Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is an important cause of ill health in women and it accounts for 12% of all gynaecology referrals in the UK. Heavy menstrual bleeding is clinically defined as greater than or equal to 80 ml of blood loss per menstrual cycle. However, women may complain of excessive bleeding when their blood loss is less than 80 ml. Hysterectomy is often used to treat women with this complaint but medical therapy may be a successful alternative. The intrauterine coil device was originally developed as a contraceptive but the addition of uterine relaxing hormones, progestogens, to these devices resulted in a large reduction in menstrual blood loss. Case studies of two types of progesterone or progestogen-releasing systems, Progestasert and Mirena, reported reductions of up to 90% and that dysmenorrhoea may be improved. Insertion, however, may be regarded as invasive by some women, which affects its acceptability as a treatment. Frequent intermenstrual bleeding and spotting is also likely during the first few months. OBJECTIVES: To determine the effectiveness and acceptability of progesterone or progestogen-releasing intrauterine devices in achieving a reduction in heavy menstrual bleeding. SEARCH STRATEGY: All studies which might describe randomised controlled trials of progesterone or progestagen-releasing intrauterine devices for the treatment of heavy menstrual bleeding were obtained by electronic searches of The Cochrane Library, MEDLINE (1966 to 2005) and EMBASE (1980 to 2005). Companies producing progestogen-releasing intrauterine devices and experts in the field were contacted for information on published and unpublished trials. SELECTION CRITERIA: Randomised controlled trials in women of reproductive age treated with progesterone or progestogen-releasing intrauterine devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding within primary care, family planning or specialist clinic settings were eligible for inclusion. Women with postmenopausal bleeding, intermenstrual or irregular bleeding, or pathological causes of heavy menstrual bleeding were excluded. DATA COLLECTION AND ANALYSIS: Potential trials were independently assessed by three review authors and nine trials met the criteria for inclusion in the review. The reviewers extracted the data independently and data were pooled where appropriate. Odds ratios (OR) were estimated from the data for dichotomous outcomes and weighted mean differences (WMD) for continuous outcomes. The primary outcome was reduction in menstrual blood loss but incidence of side effects, changes in quality of life, satisfaction and acceptability measures were also assessed. MAIN RESULTS: Progesterone or progestogen-releasing intrauterine systems have not been compared to placebo or no treatment. Progestasert has been compared to a number of different medical therapies in one small study but no conclusions can be made about its effectiveness. The levonorgestrel-releasing intrauterine device (LNG IUS) has been compared to oral cyclical norethisterone (NET) administered on days 5 to 26 of the menstrual cycle in one trial and was significantly more effective although there was a large reduction in loss from baseline in both groups. Some short term side effects were more common in the LNG IUS group but a significantly greater proportion of women in this group were satisfied and willing to continue with their treatment. In one trial of women awaiting hysterectomy, where the LNG IUS was compared with a control group taking their existing medical therapy, a higher proportion of the women in the intrauterine device group cancelled their planned surgery after six months of treatment. The LNG IUS has been compared to an endometrial ablation: either transcervical resection of the endometrium (TCRE) (two trials) or balloon ablation (three trials). There was a significantly greater mean reduction in menstrual bleeding in one trial in those undergoing balloon ablation (WMD -45.2 units, 95% CI -56.9 to -33.5), a lower score on the pictorial blood loss chart (PBAC) (WMD 33.2 units, 95% CI 27.2 to 39.2) and higher rates of successful treatment in 3 trials including both balloon and TCRE (OR 0.28, 95% CI 0.14 to 0.58) but the rates of satisfaction with treatment was were similar. There was no conclusive evidence of changes in quality of life between groups but women with the LNG IUS had a greater incidence of progestogenic side effects within one year. The LNG IUS has been compared to hysterectomy in one trial. There was no evidence of a change in quality of life scores but the LNG IUS treatment had lower costs than with hysterectomy, both at one and five-years follow up. AUTHORS' CONCLUSIONS: The levonorgestrel-releasing intrauterine device (LNG IUS) is more effective than cyclical norethisterone (for 21 days) as a treatment for heavy menstrual bleeding. Women with an LNG IUS are more satisfied and willing to continue with treatment but experience more side effects, such as intermenstrual bleeding and breast tenderness. The LNG IUS results in a smaller mean reduction in menstrual blood loss (as assessed by the PBAC chart) than endometrial ablation but there is no evidence of a difference in the rate of satisfaction with treatment. Women with an LNG IUS experience more progestogenic side effects compared to women having TCRE for treatment of their heavy menstrual bleeding but there is no evidence of a difference in their perceived quality of life. The LNG IUS treatment costs less than hysterectomy but there is no evidence of a difference in quality of life measures between these groups. There are no data available from randomised controlled trials comparing progesterone-releasing intrauterine systems to either placebo or other commonly used medical therapies for heavy menstrual bleeding.

Female↗

PubMed1995

Vaginal bleeding patterns of women using different contraceptive methods (implants, injectables, IUDs, oral pills)--an Indian experience. An ICMR Task Force Study. Indian Council of Medical Research.

Irregularity in vaginal bleeding patterns is the most common clinical side effect causing discontinuation of the method reported by the-users of the newer contraceptive methods, especially hormonal ones. An objective assessment of vaginal bleeding pattern is, therefore, critical in evaluation of a new contraceptive method for its acceptance and continued use. The menstrual diary records of women participating in clinical trials of several contraceptive methods undertaken by the Indian Council of Medical Research were analysed. It was observed that the long-acting progestogen-only hormonal contraceptives like levonorgestrel (LNG)-releasing subdermal implants Norplant or intrauterine devices (LNG-IUD) as well as injectable contraceptive NET-EN 200mg given 2 or 3 monthly produced disturbances in bleeding pattern in the majority of their users. Very heavy or prolonged bleeding, a potential health hazard was uncommon and a shift more towards infrequent bleeding was observed. In Norplant-II implants users, 75 to 80% of women had irregularities in bleeding pattern during the first year of use which improved with prolonged use. However, even at 4 years of use, about half of the users of Norplant-II implants continued to have irregular bleeding patterns. The bleeding disturbances occurred in 80% users of 200mg NET-EN injectable contraceptives also during first year of use, however unlike Norplant-II implants users, there was no improvement with prolonged use. Combined monthly injectable contraceptives containing 50mg NET-EN and 5mg estradiol valerate caused less bleeding problems with half of the users experiencing normal pattern during one year of its use. Combined low-dose oral pills, both triphasic and monophasic, produced much better cycle control as compared to any of the other hormonal contraceptive-treated groups; about 90% of combined oral pill users had normal bleeding patterns during one year of method use. The use of copper IUDs was associated with increased bleeding in 18 to 20% of women during the initial period of three months which improved with prolonged use. It was observed that the women having frequent or prolonged bleeding had discontinued the contraceptive method more often as compared to those having delayed bleeding episodes or oligomenorrhoea. However, discontinuation rates due to bleeding irregularities at one year were lower in Norplant-II implants users as compared to other long acting hormonal contraceptive methods such as injectables or IUDs in spite of similar or better bleeding patterns in women using these methods.(ABSTRACT TRUNCATED AT 400 WORDS)

Administration, Oral↗

PubMed1994

Effect of aspirin and nonsteroidal antiinflammatory drug therapy on bleeding complications in dermatologic surgical patients.

BACKGROUND: Aspirin and nonsteroidal antiinflammatory drugs (NSAIDs) inhibit platelet cyclooxygenase activity, resulting in altered platelet function and thus potentially enhanced bleeding. OBJECTIVE: We examined the frequency of operative bleeding complications in dermatologic surgical patients taking these drugs and the value of template bleeding time estimates in predicting this complication. METHODS: Bleeding time was measured with and without therapy in 23 patients and was correlated to bleeding complications after skin tumor or benign lesion excision in 40 patients taking aspirin, 21 taking NSAIDs, and 20 taking neither drug. RESULTS: Bleeding time dropped significantly (p < 0.01) when patients stopped therapy for at least 5 days (median, 7 days), although bleeding time was prolonged in only 6 of 16 patients taking aspirin and 2 of 7 taking NSAID. In patients who continued antiplatelet drugs during surgery, bleeding time was prolonged in 8 of 40 patients taking aspirin and in 1 of 21 treated with NSAIDs. Excessive intraoperative bleeding occurred in three aspirin-treated patients, all of whom had a prolonged bleeding time, compared with none of those with normal bleeding times (p < 0.001, Fisher's exact probability test) and with none of those taking NSAIDs. Postoperative ooze requiring a dressing replacement occurred in one NSAID-treated patient and in three patients taking neither drug. CONCLUSION: Bleeding time is increased by aspirin and NSAID therapy but is prolonged beyond the normal range in only approximately 25% of aspirin-treated and 10% of NSAID-treated patients. Intraoperative bleeding complications occurred only in patients receiving aspirin who had a prolonged bleeding time. Postoperative oozing occurred only in NSAID-treated and in untreated patients and thus is probably unrelated to antiplatelet therapy. Patients with a normal bleeding time can continue aspirin or NSAID therapy before dermatologic surgery.

Adult↗

PubMed1997

Rectal bleeding after conformal 3D treatment of prostate cancer: time to occurrence, response to treatment and duration of morbidity.

PURPOSE: Rectal bleeding is the most common late sequelae of high-dose 3D conformal treatment (3DCRT) for prostate cancer and may limit attempts to improve local control by dose escalation. The clinical course of this complication is reported including time to onset, response to treatment, duration of morbidity, and multivariate analysis for predictors. METHODS AND MATERIALS: From March 1989 to June 1995, 670 patients with prostate cancer were treated with 3DCRT at Fox Chase Cancer Center. Eighty-nine patients developed Grade 2 or Grade 3 complications due to rectal bleeding and are analyzed. Multivariate analysis results for predictors of Grade 2 and 3 rectal bleeding are reported as well as time to development, response to initial and retreatment, and duration of morbidity. RESULTS: The median time to occurrence is not significantly different (p = 0.09) for Grade 2 (13 months, range 4-41 months) compared to Grade 3 rectal bleeding (18 months, range 4-40 months), while the corresponding median duration of symptoms was significantly different (p < 0.0001) being 1 month (range 1-12) vs. 10 months (1-34) for Grade 2 and Grade 3 bleeding, respectively. For Grade 2 bleeding, medication or coagulation was highly effective as initial or retreatment resolving 66 of 73 patients. For Grade 3 bleeding, three patients responded without medication following blood transfusion only, while with multiple coagulations and medication 12 of 16 patients improved to < or = Grade 1. Multivariate analysis demonstrates that dose is the only significant factor associated with Grade 2 (p = 0.01) or Grade 3 (p = 0.01) rectal bleeding. Of seven nonresponders to treatment for Grade 2 bleeding, three have died of intercurrent disease at 10, 19, and 26 months, while four are alive with continuing Grade 2 bleeding at 12, 14, 15, and 30 months after onset. The four nonresponders to treatment for Grade 3 bleeding continue to bleed 1, 9, 32, and 35 months after the third coagulation despite continuing care. CONCLUSIONS: Chronic rectal bleeding is a sequelae of high-dose conformal treatment of prostate cancer. Grade 2 morbidity responds to medication or limited coagulation (< or = 2) in 90% of patients. Grade 3 morbidity responds to medication and multiple coagulations (> or = 3) in 75% of patients. The chronicity of Grade 3 morbidity is illustrated by a 10-month median duration for response to treatment, with a range of response extending to 34 months. Nonresponders to treatment have continued to bleed up to 35 months after the third coagulation. Appropriate shielding of the rectal mucosa limiting dose to < 72 Gy is required to avoid a high incidence of these complications, as dose is the only significant variable associated with rectal bleeding.

Aged↗

PubMed2003

Methodologic issues in the use of bleeding as an outcome in transfusion medicine studies.

BACKGROUND: Prophylactic platelet transfusions are given to thrombocytopenic patients to prevent bleeding. The benefit of platelet transfusions has frequently been assessed by measuring the count increment; however, more recently, an assessment of bleeding has been used because it is a more clinically relevant outcome measure. The purpose of this study was to identify platelet transfusion trigger studies that used bleeding as an outcome measure, compare and contrast methods used to document bleeding and analyze bleeding outcomes, and identify and discuss methodologic issues to consider when bleeding is used as a study outcome. STUDY DESIGN AND METHODS: A systematic search to identify platelet transfusion trigger studies was performed. Relevant articles were reviewed to identify how bleeding data was captured and analyzed, and methodologic considerations were identified. RESULTS: Seven articles meeting the predefined entry criteria were identified. Methods used to document bleeding included chart review and clinical assessment. The frequency of assessment and the type of personnel performing the assessment were variable. Four approaches to analysis were identified: descriptive; comparison of the proportions of patients having at least one bleed; comparison of patient days with bleeding expressed as a proportion of the total days at risk of bleeding; and time-to-event (first bleed) analysis. CONCLUSION: Methodologic issues for consideration when designing a clinical study with bleeding as the outcome measure included approaches to minimize bias in the documentation and classification of bleeding and selection of an analysis approach that is appropriate to the question being asked. The need for development of a valid and reliable bleeding scale was also identified.

Data Collection↗

PubMed1999

Differences in menstrual bleeding characteristics, functional status, and attitudes toward menstruation in three groups of women.

This report examines differences in bleeding characteristics, functional status, and attitudes toward menstruation among three groups of women: (1) women who complain of abnormal uterine bleeding (AUB), (2) women who have similar menstrual patterns as those complaining of AUB but who do not perceive themselves to have abnormal bleeding, and (3) women without evidence of prolonged or excessive bleeding. Women who complain of AUB and women with heavy bleeding but not complaining of AUB, although similar on two important menstrual symptoms (very heavy bleeding or episodes of unusually heavy bleeding) differ on a number of other menstrual characteristics, including the frequency of short cycles, the probability of having an abnormally long period, and reporting of unusually heavy bleeding lasting longer than 1 day. Whether women reported concerns with menstruation or not, the majority of women in this analysis had fairly negative attitudes toward menstruation. However, this negativity toward menstruation did not translate into women wanting a hysterectomy, even for those with heavy bleeding. The major difference among the three groups of women was the strong negative effect of AUB on functional status. A majority of women complaining of AUB reported that the bleeding interfered significantly with their daily routine, making them unable to function at work and at home. These results suggest that although the main complaint of women with AUB is very heavy bleeding, a number of other specific menstrual characteristics differentiate women with AUB from other women with very heavy bleeding who do not perceive the bleeding to be problematic. The complaint of AUB appears to be related to how significantly bleeding affects daily functioning. Therefore, an important factor to assess when considering treatment of AUB is the extent to which bleeding symptoms significantly affect functional status.

Adult↗

PubMed2005

Postoperative tonsillectomy bleed: coblation versus noncoblation.

OBJECTIVE: To examine the incidence of postoperative bleeding after coblation and noncoblation tonsillectomy and to use postoperative bleeding as an outcome measure to determine the presence of a learning curve with this new surgical technique. STUDY DESIGN: A retrospective review of records from January 1999 to April 2003 to determine type of tonsillectomy performed and the presence of postoperative bleeding. A chi-square analysis was used to determine a statistical difference between the postoperative bleed rate of coblation and noncoblation procedures. The examined time period was divided into 3-month intervals, and the coblation postoperative bleeds were tallied for each interval. The Cochraine-Armitage test of linear trend was used to assess change in the postoperative bleeds. RESULTS: One thousand seven hundred sixty-two tonsillectomies were performed. The postoperative bleed rate for noncoblation tonsillectomy was 6.1% (74/1,216). The bleeding rate for coblation tonsillotomy was 5.9% (18/303) and 5.4% (13/239) for coblation tonsillectomy. There was no statistical difference (P = .93) between bleed rates for coblation versus noncoblation techniques. There was no difference in the need for operative intervention to control postoperative bleeding: 16.2% (12/74) for noncoblation technique and 25.85 (8/31) for coblation procedures (P = .25). The postoperative coblation bleed rates for the 3-month periods did not reveal an increasing or decreasing trend in the postoperative bleed rate (P = .49). CONCLUSION: Coblation is a safe procedure for performing tonsil surgery with no significant difference in postoperative bleeding from previous techniques and no increased need for operative intervention to control postoperative bleeding. A learning curve could not be identified when using postoperative bleeding as an outcome measure for coblation tonsillectomy.

Humans↗

PubMed2004

Bleeding manifestations in males with von Willebrand disease.

von Willebrand disease (vWD) is the most common congenital bleeding disorder in the USA, affecting 1-3% of the population. Previously characterizing the bleeding symptoms in females with type 1 vWD, we evaluated 42 males with type 1 vWD, mean age 16 years (1-64), of whom 24 (57%) presented with bleeding symptoms. The most common initial symptom was postoperative bleeding (26%). The most common bleeding symptoms ever were epistaxis (53%), bruising (50%), postoperative bleeding (47%), haematomas (29%) and oral bleeding (29%). Of postoperative bleeding, ear/nose/throat (44%), dental (17%) and circumcision bleeding (22%) occurred at a median 10 years of age, despite a previous bleeding or family history in 89%. Complications included anaemia in five (12%), neurological sequelae after subdural haematoma and tonsillectomy in two (5%), transfusion-associated hepatitis C in two (5%) and degenerative joint disease after traumatic haemarthroses in one (2%). The bleeding time (BT) was prolonged in 83%, and the ristocetin cofactor (vW:RCoF) and factor VIII (FVIII:C) decreased in 64% and 43%, respectively. Haemarthroses and haematoma formation were associated with a longer activated partial thromboplastin time (APTT) (P < 0.05), and anaemia with a lower FVIII:C (P < 0.05). In 81%, a haemostatic response occurred with 1-8 deamino-d-arginine vasopressin (DDAVP), although, in 13%, surgical intervention was also required to achieve haemostasis. Postoperative bleeding could have been avoided in 89%, if a preoperative past bleeding history or family history had been obtained, and, in at least 94%, if a preoperative BT and APTT had also been performed. The failure to avoid postoperative bleeding and related complications in patients with vWD by taking a personal and family bleeding history constitutes a major public health problem.

Adolescent↗

PubMed2003

Endoscopic sclerotherapy compared with no specific treatment for the primary prevention of bleeding from esophageal varices. A randomized controlled multicentre trial [ISRCTN03215899].

BACKGROUND: Since esophageal variceal bleeding is associated with a high mortality rate, prevention of bleeding might be expected to result in improved survival. The first trials to evaluate prophylactic sclerotherapy found a marked beneficial effect of prophylactic treatment. These results, however, were not generally accepted because of methodological aspects and because the reported incidence of bleeding in control subjects was considered unusually high. The objective of this study was to compare endoscopic sclerotherapy (ES) with nonactive treatment for the primary prophylaxis of esophageal variceal bleeding in patients with cirrhosis. METHODS: 166 patients with esophageal varices grade II, III of IV according to Paquet's classification, with evidence of active or progressive liver disease and without prior variceal bleeding, were randomized to groups receiving ES (n = 84) or no specific treatment (n = 82). Primary end-points were incidence of bleeding and mortality; secondary end-points were complications and costs. RESULTS: During a mean follow-up of 32 months variceal bleeding occurred in 25% of the patients of the ES group and in 28% of the control group. The incidence of variceal bleeding for the ES and control group was 16% and 16% at 1 year and 33% and 29% at 3 years, respectively. The 1-year survival rate was 87% for the ES group and 84% for the control group; the 3-year survival rate was 62% for each group. In the ES group one death occurred as a direct consequence of variceal bleeding compared to 9 in the other group (p = 0.01, log-rank test). Complications were comparable for the two groups. Health care costs for patients assigned to ES were estimated to be higher. Meta-analysis of a large number of trials showed that the effect of prophylactic sclerotherapy is significantly related to the baseline bleeding risk. CONCLUSION: In the present trial, prophylactic sclerotherapy did not reduce the incidence of bleeding from varices in patients with liver cirrhosis and a low to moderate bleeding risk. Although sclerotherapy lowered mortality attributable to variceal bleeding, overall survival was not affected. The effect of prophylactic sclerotherapy seems dependent on the underlying bleeding risk. A beneficial effect can only be expected for patients with a high risk for bleeding.

Adult↗

PubMed2006

Mechanisms of irregular bleeding with hormone therapy: the role of matrix metalloproteinases and their tissue inhibitors.

CONTEXT: Irregular bleeding is common in users of combined hormone therapy (HT) and often leads to invasive and expensive investigations to exclude underlying pathology. The mechanisms of HT-related bleeding are poorly understood. Endometrial matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs) are believed to regulate bleeding during the normal menstrual cycle and are known to be altered in breakthrough bleeding with progestogen-only contraception. OBJECTIVE: The aim of this study was to determine how HT exposure alters endometrial production of MMP-1, -3, -9, and -14 and their tissue inhibitors TIMP-1, -2, -3, and -4 and to determine the relationship between MMP and TIMP production and bleeding patterns in HT users. Endometrial leukocytes regulating MMP production and activation were also assessed. DESIGN: A prospective observational study was conducted between 2003 and 2005. SETTING AND PATIENTS: The study occurred at a tertiary referral menopause clinic at King Edward Memorial Hospital, Western Australia, and included 25 postmenopausal women not taking HT and 73 women taking combined HT. INTERVENTIONS: Endometrium was obtained during and outside bleeding episodes. MAIN OUTCOME MEASURES: We assessed production of MMP-1, -3, -9, and -14 and their tissue inhibitors TIMP-1, -2, -3, and -4 and their relationship to bleeding patterns in HT users. RESULTS: All MMPs studied, with the exception of MMP-9, were expressed at low levels in postmenopausal endometrium. Increases in both MMP-3 and -9 localization were seen in association with irregular bleeding, but these did not reach statistical significance. Endometrial production of TIMP-1 was significantly increased in association with bleeding. Endometrial leukocytes were not related to bleeding, with the exception of uterine natural killer cells, which were significantly increased during bleeding, as previously published. CONCLUSIONS: Irregular bleeding in HT users is associated with a distinct pattern of MMP and TIMP production that differs from that seen in normal menstrual bleeding and from that seen in contraceptive-related breakthrough bleeding. This suggests that the endometrial balance between MMP and TIMP contributes to vascular breakdown with HT but by a different mechanism than that seen in normal menstruation or in breakthrough bleeding.

Biopsy↗

PubMed2007

Discrepancies in identification of bleeding events after percutaneous coronary intervention.

STUDY OBJECTIVE: To evaluate the level of agreement between two sets of criteria, the Thrombolysis in Myocardial Infarction (TIMI) criteria and investigator-developed criteria, for identifying bleeding events in patients who had undergone a percutaneous coronary intervention (PCI) and to measure length of hospital stay (LOS) as a surrogate marker of bleeding severity. DESIGN: Retrospective chart review. SETTING: Two university-affiliated medical centers. PATIENTS: Four hundred twenty-two consecutive patients who had undergone PCI from December 1, 2001-June 30, 2002. MEASUREMENTS AND MAIN RESULTS: Data were collected on the number of bleeding events that occurred within 1 week after PCI (limited to one event/patient) and on LOS. Bleeding was assessed by TIMI criteria and by investigator-developed criteria. Bleeding according to TIMI criteria included intracranial hemorrhage, spontaneous hematuria or hematemesis, or decreases in hemoglobin level. Bleeding according to investigator-developed criteria included intracranial, retroperitoneal, intraocular, or clinically overt bleeding without a specified decrease in hemoglobin level. Agreement between criteria was assessed by means of the kappa statistic. Of the 422 patients, 23 (5%) experienced TIMI-defined bleeding events and 229 (54%) investigator-defined bleeding events. A kappa value of 0.09 (95% confidence interval 0.06-0.13) indicated a poor level of agreement between the two sets of bleeding criteria. The effect of this discrepancy on LOS was 66 fewer days of care when TIMI criteria were applied versus investigator-developed criteria in the 206 patients who experienced bleeding events that met investigator criteria (total LOS 645 days) but not TIMI criteria (total LOS 579 days). CONCLUSION: Bleeding assessment with use of TIMI criteria versus investigator-developed criteria yielded discrepant bleeding event rates and LOS, making it difficult to accurately compare bleeding rates and consequences across clinical trials and in practice. Consensus bleeding criteria are needed for applications in clinical evaluations of antithrombotic agents.

Angioplasty, Balloon, Coronary↗

PubMed1996

Indices to measure gingival bleeding.

Gingival bleeding is an objective, easily assessed sign of inflammation that is associated with several periodontal diseases. Many bleeding indices have been devised; some assess bleeding as simply present or absent, whereas others use grading in an attempt to assess severity of bleeding. The choice of which index to use depends on whether the purpose is an epidemiological survey, a clinical study, diagnosis and treatment, or patient motivation. Bleeding may be elicited manually with toothpicks, dental floss or a periodontal probe, but a controlled-force probe, although more expensive, causes less trauma and less false-positive bleeding from healthy tissues. As a predictor of periodontal disease progression, bleeding on probing has low sensitivity owing to a high frequency of false-positive responses, but has high specificity in that failure to bleed indicates health. There is evidence that smokers have less, or delayed, gingival bleeding when compared with non-smokers; therefore smoking needs to be controlled for in studies of gingival bleeding. Measurement of gingival bleeding tendency should be an integral part of a comprehensive oral examination. In clinical practice, the use of a graded bleeding index is more likely to identify sites that are at risk of further destructive activity. For monitoring individual patients, both for response to initial therapy and during maintenance, a modified Sulcus Bleeding Index (mSBI) with three bleeding scores is recommended in preference to dichotomous scoring of bleeding.

Gingival Hemorrhage↗

PubMed2004

Diagnosis of Helicobacter pylori infection using urease rapid test in patients with bleeding duodenal ulcer: influence of endoscopic signs and simultaneous corporal and antral biopsies.

INTRODUCTION: The sensitivity of invasive diagnostic methods for Helicobacter pylori (H. pylori) infection, particularly of urease rapid test, is decreased in cases of gastroduodenal ulcer and upper gastrointestinal bleeding. OBJECTIVES: To assess the influence of blood in the stomach or recent bleeding endoscopic signs in the diagnostic sensitivity of urease rapid test among patients with bleeding duodenal ulcer, as well as the influence of simultaneously collecting corporal and antral biopsy samples. PATIENTS AND METHODS: 120 patients, 85 male and 35 female, with an average age of 62 (18-88) years, who were admitted to our Hospital due to bleeding duodenal ulcer and who received an endoscopic diagnosis within 24 hours of admission were included. None of the patients had been under treatment with non-steroideal antiinflammatory drugs, proton-pump inhibitors or antimicrobial drugs in the two weeks prior to the bleeding event, and none had received eradicating therapy for H. pylori. In this group of selected patients an H. pylori infection rate nearing 100% was assumed. H. pylori infection was ruled out using antral biopsy (69 cases) or both antral and fundic biopsies (51 cases) for urease rapid testing (Jatrox-H.p.-Test). Patients were classified in three groups according to their endoscopic bleeding signs: a) presence of blood in the stomach or recent bleeding ulcer (21 cases); b) ulcer showing non-recent bleeding signs (38 cases); and c) ulcer without bleeding signs (61 cases). The sensitivity of the urease rapid test was compared between patient groups. Similarly, urease test results with an antral biopsy sample were compared in 100 patients with non-bleeding duodenal ulcer. RESULTS: Urease test was positive in 93% of patients with non-bleeding duodenal ulcer, and in 83% of patients with upper gastrointestinal bleeding, which reached statistical significance (p = 0.019). This test was positive in 82.6% of patients with an antral biopsy, and in 82.3% of patients with combined antral and fundic biopsies. In group A, urease test was positive in 90.5% of patients; in group B, it was positive in 89.5% of patients, and in group C, the test turned positive in 75.4% of patients. Statistical differences were only reached when patients in group C were compared to patients in groups A and B together (p = 0.037). CONCLUSIONS: 1. The presence of either blood in the stomach or recent bleeding endoscopic signs appeared not to be the conditioning factor for the decreased sensitivity of urease test among patients with bleeding duodenal ulcer. 2. The decreased sensitivity of this test in patients with upper gastrointestinal bleeding is more evident during the resolution stage, and it does not seem to occur because of H. pylori migration from the antrum to the corporal gastric region.

Adolescent↗

PubMed1996

Risk factors for bleeding during treatment of acute venous thromboembolism.

OBJECTIVE: Identification of risk factors for bleeding and prospective evaluation of two bleeding risk scores in the treatment of acute venous thromboembolism. DESIGN: Secondary analysis of a prospective, randomized, assessorblind, multicenter clinical trial. SETTING: One university and 2 regional teaching hospitals. PATIENTS: 188 patients treated with heparin or danaparoid for acute venous thromboembolism. MEASUREMENTS: The presenting clinical features, the doses of the drugs, and the anticoagulant responses were analyzed using univariate and multivariate logistic regression analysis in order to evaluate prognostic factors for bleeding. In addition, the recently developed Utrecht bleeding risk score and Landefeld bleeding risk index were evaluated prospectively. RESULTS: Major bleeding occurred in 4 patients (2.1%) and minor bleeding in 101 patients (53.7%). For all (major and minor combined) bleeding, body surface area < or = 2 m2 (odds ratio 2.3, 95% CI 1.2-4.4; p = 0.01), and malignancy (odds ratio 2.4, 95% CI 1.1-4.9; p = 0.02) were confirmed to be independent risk factors. An increased treatment-related risk of bleeding was observed in patients treated with high doses of heparin, independent of the concomitant activated partial thromboplastin time ratios. Both bleeding risk scores had low diagnostic value for bleeding in this sample of mainly minor bleeders. CONCLUSIONS: A small body surface area and malignancy were associated with a higher frequency of bleeding. The bleeding risk scores merely offer the clinician a general estimation of the risk of bleeding. In patients with a small body surface area or in patients with malignancy, it may be of interest to study whether limited dose reduction of the anticoagulant drug may cause less bleeding without affecting efficacy.

Acenocoumarol↗

PubMed1996

[Vaginal bleeding patterns and the regularity in use of Norplant].

OBJECTIVES: To understand vaginal bleeding patterns and the regularity in use of Norplant, and find out the main cause of termination that Norplant users can not bear. METHODS: A total of 306 menstrual diaries of Norplant users for 5 years were analyzed. The analysis of bleeding patterns was carried out by using the reference period approach and followed the guidelings published by WHO. RESULTS: The total number of vaginal bleeding days and the number of spotting days in the first reference periods were 36.6 days and 21.5 days, respectively. They were decreased obviously in the third reference period. The number of bleeding days was not obviously changed. The percentage of irregular bleeding was predominent in all of the bleeding patterns, 43.1%-57.6% usually. The percentage of prolonged bleeding was 13.4%-31.0%, secondly. The percentage of "normal" was only 33%. The number of bleeding days and the percentage of prolonged bleeding were more in bleeding termination group than in continuation group. The percentage of irregular bleeding was lower. CONCLUSIONS: During the initial stage of use of Norplant the total number of vaginal bleeding days was increased, but decreased obviously after 6 months. This change was influenced by the number of spotting days. Irregular bleeding and prolonged bleeding were main types of the disturbance of menstrual cycles after use of Norplant, The main cause of termination was prolonged bleeding.

Adult↗