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Recent nonsteroidal anti-inflammatory drug use increases the risk of early recurrence of bleeding in patients presenting with bleeding ulcer.

BACKGROUND: Nonsteroidal anti-inflammatory drug (NSAID) use is a well-known risk factor for ulcer formation and ulcer complications. The purpose of this study was to determine whether recent NSAID use increases the risk of early recurrence of bleeding in patients who present with bleeding ulcer. METHODS: Clinical and endoscopic data were collected prospectively. Dose, frequency, and duration of recent NSAID use were quantified. Recent NSAID use was defined as consumption of over-the-counter or prescription NSAIDs or aspirin for at least 5 days of the 2-week period preceding the index episode of bleeding. Endoscopy was performed within 24 hours of admission to confirm the source of bleeding and endoscopic intervention was applied for stigmata of bleeding. Early recurrence of bleeding was defined as melena, hematochezia or blood per nasogastric tube with a 2 gm or greater decrease in hemoglobin during a period of 48 hours, occurring less than 2 weeks from index episode of bleeding. RESULTS: One hundred twenty patients (52 NSAID users and 68 nonusers) were enrolled in the study; mean age was 56 years. NSAID users were older than nonusers (p = 0.003); nonusers were more likely to have a history of ulcer disease (p < 0.0005) and higher prevalence of Helicobacter pylori infection (p = 0.05). Recent NSAID use was associated with a significantly higher frequency of early recurrence of bleeding and in-hospital recurrent bleeding compared with nonusers: 19% vs. 6%, p = 0.02, and 17% vs. 6%, p = 0.04, respectively. In multivariate logistic regression analysis, the significant association between recent NSAID use and early recurrence of bleeding persisted (p = 0.0048) while controlling for age and other covariates. CONCLUSIONS: Recent NSAID use predisposes bleeding ulcer patients to early and in-hospital recurrent bleeding, probably via its effects on platelet function, mucosal prostaglandins, and ulcer healing.

Adult↗

Presence of bacterial infection in bleeding cirrhotic patients is independently associated with early mortality and failure to control bleeding.

Bacterial infection is strongly associated with gastrointestinal bleeding in cirrhotic patients and seems to be related with the failure to control bleeding. The aims of this study were to assess the influence of infections on the failure to control bleeding and death in cirrhotic patients without antibiotic prophylaxis. Ninety-one consecutive bleeding cirrhotic patients were analyzed. Bleeding was managed using somatostatin with sclerotherapy for active bleeding. Screening for bacterial infection (analysis and culture of blood, urine, ascitic and other fluids, together with chest radiography) was made at time 0 and when clinical signs suggested infection. The cause of bleeding was variceal in 72 (79%) patients. Failure to control bleeding occurred in 24 (26%) patients, and 10 (11%) of the patients died. Compared with the group without infection, failure to control bleeding (65% vs 15%; P < 0.001) and mortality (40% vs 3%; P < 0.001), were observed more frequently in patients with infection. Multivariate analysis showed that bacterial infection (OR = 9.7; P < 0.001) and the presence of shock (OR = 3.5; P < 0.05) were independently associated with failure to control bleeding. Bacterial infection (OR = 12.6; P < 0.01), encephalopathy (OR = 6.9; P < 0.05), and shock (OR = 5.8; P < 0.05) were identified as predictive of death. In conclusion, in bleeding cirrhotic patients bacterial infection is associated with failure to control bleeding as well as mortality.

Female↗

Feasibility and usefulness of self-assessment of bleeding in patients with haematological malignancies, and the association between platelet count and bleeding.

BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate the collection of daily prospective information about bleeding outcomes in patients with thrombocytopenia, including information obtained by patient self-assessment. MATERIALS AND METHODS: Consecutive patients with haematological malignancies were enrolled in a study of bleeding data collection during the period of thrombocytopenia. A short educational session and information sheet was designed for self-assessment. Platelet counts and all transfusions were recorded daily. Bleeding scores were translated into World Health Organization (WHO) bleeding grades. RESULTS: Nineteen patients were included in the study. Four-hundred and ten days of thrombocytopenia were eligible for assessment of bleeds. Self-assessment was feasible, as defined by the total proportion of days on which self-assessment was completed (70%, 288 thrombocytopenic days). There was 86% agreement between bleeding data collected by self-assessment and by medical examination using a structured assessment form. Examples of discrepancies included the duration of petechiae/bruises and the reporting of minor bleeding. There was no evidence for an association between patients' morning platelet count and daily WHO bleeding grade. The incidences of WHO grade 1 and grade 2 bleeding on days with platelet counts < or = 10 x 10(9)/l, 11-20 x 10(9)/l, and > 20 x 10(9)/l were similar and did not reveal higher rates of bleeding at lower counts. CONCLUSIONS: Patient self-assessment can help to support comprehensive daily prospective monitoring of bleeding, specifically facilitating data collection following hospital discharge. The discrepancies between self-assessment and medical examination highlight the need to develop a validated international assessment tool. The association among platelet count, risk of bleeding and role of prophylactic platelet transfusions needs further evaluation in larger prospective trials.

Female↗

Treatment of small bleeding varicose veins with injection sclerotherapy. Bleeding blue blebs.

BACKGROUND: Bleeding is a well-recognized but seemingly uncommon complication of varicose vein disease. Some deaths have occurred in which bleeding developed from vessels in the base of chronic venous ulcers. OBJECTIVE: To elucidate a more common type of venous bleeding that can be identified and treated by an experienced sclerotherapist. METHODS: The records of a group of patients with bleeding superficial phlebectasias, primarily on the feet and ankles, are reviewed. All patients received injection sclerotherapy after the initial bleeding episode. A comparison was made between those patients whose bleeding points were sutured in the emergency department and those who were treated only with compression. RESULTS: Suture-ligation of the bleeding site delayed healing when compared with simple compression. Concomitant injection sclerotherapy proved to be a successful and permanent method of treating these veins. No recurrent bleeding developed in any of the patients, even in those with previous episodes of bleeding. CONCLUSIONS: Initial treatment of the bleeding blue bleb requires only compression of the tiny open vessel. Later injection sclerotherapy provides a permanent method of obliterating the thin-walled veins and prevents future bleeding. It is essential to treat the entire incompetent venous system as well as the bleeding site itself.

Adult↗

Correlation between template bleeding times and spontaneous bleeding during treatment of acute myocardial infarction with recombinant tissue-type plasminogen activator.

The purpose of this study was to correlate bleeding complications during and after treatment with recombinant tissue-type plasminogen activator (rt-PA) with serial template bleeding time measurements, with ADP-induced platelet aggregation, with clinical characteristics, and with hemostatic parameters. Fifty-two of 55 consecutive patients with acute myocardial infarction and template bleeding times (Ivy method) of less than 9.5 minutes were treated with rt-PA in a total dose of 55-212 mg (mean, 109 mg) over 90 to 360 minutes (median, 240 minutes) combined with heparin. The mean bleeding time was significantly prolonged at 90 minutes (from 5.0 +/- 1.9 to 8.2 +/- 4.3 minutes, p less than 0.0001) but returned toward baseline after 4 hours (from a median of 8.0 to 7.0 minutes, p less than 0.05). Thirteen patients (25%) suffered relatively minor but spontaneous bleeding that did not correlate with age, hypertension, smoking, partial thromboplastin time, platelet count, ADP-induced platelet aggregation, steady-state rt-PA level, or extent of fibrinogen degradation. In multivariate analysis, only the 90-minute bleeding time correlated with spontaneous bleeding (p = 0.01). Prolongation of the 90-minute bleeding time to greater than or equal to 9 minutes, which occurred in 21 patients, correlated with spontaneous bleeding with a sensitivity of 69% (95% confidence interval, 39-90%) and a specificity of 69% (95% confidence interval, 52-83%). Retrospective analysis revealed that in 14 patients taking aspirin, the bleeding time at 90 minutes was significantly more prolonged (p less than 0.05) and spontaneous bleeding significantly more frequent (p less than 0.01) than in patients not taking aspirin.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenosine Diphosphate↗

Clotting factor concentrates given to prevent bleeding and bleeding-related complications in people with hemophilia A or B.

BACKGROUND: People with severe hemophilia A or B, X-linked bleeding disorders due to decreased blood levels of coagulants, suffer recurrent bleeding into joints and soft tissues. Before clotting factor concentrates were available, most people with severe hemophilia developed crippling musculoskeletal deformities. Clotting factor concentrate prophylaxis aims to preserve joint function by converting severe hemophilia (factor VIII or IX less than 1%) into a clinically milder form of the disease. Prophylaxis has long been used in Sweden, but not universally adopted because of medical, psychosocial, and cost controversies. Use of clotting factor concentrates is the single largest predictor of cost in treating hemophilia. OBJECTIVES: To determine the effectiveness of clotting factor concentrate prophylaxis in the management of people with hemophilia A or B. SEARCH STRATEGY: We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references from comprehensive electronic database searches and handsearches of journals and abstract books. Reference lists of relevant articles were reviewed. Most recent search: January 2002. SELECTION CRITERIA: Randomized controlled trials (RCTs) evaluating people with severe hemophilia A or B, receiving prophylactic clotting factor concentrates. DATA COLLECTION AND ANALYSIS: Two reviewers independently reviewed studies for eligibility, assessed methodological quality and extracted data. MAIN RESULTS: Twenty-nine studies were identified, of which four (including 37 participants) were eligible for inclusion. Three studies evaluated hemophilia A; one showed a decrease in frequency of joint bleeds with prophylaxis compared to placebo (non-physiological dose), with a rate difference (RD) -10.80 (95% confidence interval (CI) -16.33 to -5.27) bleeds per year. The remaining two studies evaluating hemophilia A compared two prophylaxis regimens, one study showed no difference in joint bleed frequency, RD -5.04 (95%CI -17.02 to 6.94) bleeds per year and another failed to demonstrate an advantage of factor VIII dosing based on individual pharmacokinetic data over the standard prophylaxis regimen with RD -0.14 (95% CI -1.34 to 1.05) bleeds per year. The fourth study evaluated hemophilia B and showed fewer joint bleeds with weekly (15 IU/kg) versus bi-weekly (7.5 IU/kg) prophylaxis, RD -3.30 (95% CI -5.50 to - 1.10) bleeds per year. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether prophylactic clotting factor concentrates decrease bleeding and bleeding-related complications in hemophilia A or B, compared to placebo, on-demand treatment, or prophylaxis based on pharmacokinetic data from individuals. Well-designed RCTs are needed to assess the effectiveness of prophylactic clotting factor concentrates. Two clinical trials are ongoing.

Blood Coagulation Factors↗

Clotting factor concentrates given to prevent bleeding and bleeding-related complications in people with hemophilia A or B.

BACKGROUND: People with severe hemophilia A or B, X-linked bleeding disorders due to decreased blood levels of coagulants, suffer recurrent bleeding into joints and soft tissues. Before clotting factor concentrates were available, most people with severe hemophilia developed crippling musculoskeletal deformities. Clotting factor concentrate prophylaxis aims to preserve joint function by converting severe hemophilia (factor VIII or IX less than 1%) into a clinically milder form of the disease. Prophylaxis has long been used in Sweden, but not universally adopted because of medical, psychosocial, and cost controversies. Use of clotting factor concentrates is the single largest predictor of cost in treating hemophilia. OBJECTIVES: To determine the effectiveness of clotting factor concentrate prophylaxis in the management of people with hemophilia A or B. SEARCH STRATEGY: We searched the Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references from comprehensive electronic database searches and handsearches of journals and abstract books. Reference lists of relevant articles were reviewed. Most recent search: November 2005. SELECTION CRITERIA: Randomized controlled trials (RCTs) evaluating people with severe hemophilia A or B, receiving prophylactic clotting factor concentrates. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed studies for eligibility, assessed methodological quality and extracted data. MAIN RESULTS: Twenty-nine studies were identified; four studies (including 37 participants) were eligible for inclusion. Three studies evaluated hemophilia A; one showed a decrease in frequency of joint bleeds with prophylaxis compared to placebo (non-physiological dose), with a rate difference (RD) -10.80 (95% confidence interval (CI) -16.33 to -5.27) bleeds per year. The remaining two studies evaluating hemophilia A compared two prophylaxis regimens, one study showed no difference in joint bleed frequency, RD -5.04 (95%CI -17.02 to 6.94) bleeds per year and another failed to demonstrate an advantage of factor VIII dosing based on individual pharmacokinetic data over the standard prophylaxis regimen with RD -0.14 (95% CI -1.34 to 1.05) bleeds per year. The fourth study evaluated hemophilia B and showed fewer joint bleeds with weekly (15 IU/kg) versus bi-weekly (7.5 IU/kg) prophylaxis, RD -3.30 (95% CI -5.50 to - 1.10) bleeds per year. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to determine whether prophylactic clotting factor concentrates decrease bleeding and bleeding-related complications in hemophilia A or B, compared to placebo, on-demand treatment, or prophylaxis based on pharmacokinetic data from individuals. Well-designed RCTs are needed to assess the effectiveness of prophylactic clotting factor concentrates. Two clinical trials are ongoing.

Blood Coagulation Factors↗

Oral estrogens decrease bleeding time and improve clinical bleeding in patients with renal failure.

PURPOSE: A prolonged bleeding time is associated with platelet dysfunction and clinical bleeding in patients with renal failure. Parenteral estrogens have been shown to shorten the prolonged bleeding time in patients with chronic renal failure, although the mechanism of action is unknown. We conducted a study to evaluate the efficacy of oral conjugated estrogens in this setting. PATIENTS AND METHODS: Four patients with renal failure, prolonged bleeding time, and clinical bleeding were given 50 mg of conjugated estrogen (Premarin) daily. RESULTS: Bleeding time normalized in two cases and was reduced to less than 50% of the pretreatment value in one of the remaining two cases. Bleeding stopped in all patients within two days. Ten dialysis patients with prolonged bleeding time were randomized to a course of 50 mg of Premarin daily or placebo. The bleeding time in all five patients in the Premarin group normalized or decreased to below 50% of the pretreatment value after 7.0 +/- 4.2 days of therapy. The bleeding time did not normalize in the five patients treated with placebo. No side effects attributable to therapy were reported. CONCLUSION: We conclude that orally administered conjugated estrogens effectively improve the bleeding tendency in patients with chronic renal failure.

Administration, Oral↗

Effect of oral esomeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.

BACKGROUND: After endoscopic treatment of bleeding peptic ulcer, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding. The role of oral proton pump inhibitors for these patients is uncertain. The purpose of the present study was to assess whether the use of oral esomeprazole would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. METHODS: Patients with actively bleeding ulcers or ulcers with non-bleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive esomeprazole (40 mg p.o. twice daily for 3 days) or placebo. The outcome measures studied were recurrent bleeding, blood transfusion requirement, surgery and death. RESULTS: A total of 70 patients were enrolled, 35 in each group. Bleeding recurred within 30 days in two patients (5.7%) in the esomeprazole group, as compared with three (8.6%) in the placebo group (P = 0.999). Blood transfusion requirement was 2.8 +/- 1.4 units in the esomeprazole group and 2.7 +/- 1.3 units in the placebo group (P = 0.761). Duration of hospitalization was 4.82 +/- 1.8 days in the esomeprazole group and 4.58 +/- 2.7 days in the placebo group (P = 0.792). No patients needed surgery for control of bleeding and no patients died in both groups. CONCLUSIONS: After successful endoscopic treatment of bleeding peptic ulcer, oral use of esomeprazole might offer no additional benefit on the risk of recurrent bleeding.

Administration, Oral↗

Acute upper GI bleeding: did anything change? Time trend analysis of incidence and outcome of acute upper GI bleeding between 1993/1994 and 2000.

OBJECTIVE: The aim of this study was to examine recent time trends in incidence and outcome of upper GI bleeding. METHODS: Prospective data collection on all patients presenting with acute upper GI bleeding from a defined geographical area in the period 1993/1994 and 2000. RESULTS: Incidence decreased from 61.7/100,000 in 1993/94 to 47.7/100,000 persons annually in 2000, corresponding to a 23% decrease in incidence after age adjustment (95% CI = 15-30%). The incidence was higher among patients of more advanced age. Rebleeding (16% vs 15%) and mortality (14% vs 13%) did not differ between the two time periods. Ulcer bleeding was the most frequent cause of bleeding, at 40% (1993/94) and 46% (2000). Incidence remained stable for both duodenal and gastric ulcer bleeding. Almost one half of all patients with peptic ulcer bleeding were using nonsteroidal anti-inflammatory drugs or aspirin. Also, among patients with ulcer bleeding, rebleeding (22% vs 20%) and mortality (15% vs 14%) did not differ between the two time periods. Increasing age, presence of severe and life-threatening comorbidity, and rebleeding were associated with higher mortality. CONCLUSIONS: Between 1993/1994 and 2000, among patients with acute upper GI bleeding, the incidence rate of upper GI bleeding significantly decreased, but no improvement was seen in the risk of rebleeding or mortality in these patients. The incidence rate of ulcer bleeding remained stable. Prevention of ulcer bleeding is important.

Acute Disease↗

Low-dose aspirin in nulliparous women: safety of continuous epidural block and correlation between bleeding time and maternal-neonatal bleeding complications. National Institute of Child Health and Human Developmental Maternal-Fetal Medicine Network.

OBJECTIVE: Our purpose was to determine the frequency and safety of the use of epidural anesthesia and the correlation between bleeding time and maternal-neonatal bleeding complications in a group of pregnant women who participated in a multicenter trial of low-dose aspirin in pregnancy. STUDY DESIGN: Data regarding type of anesthesia used for labor and delivery were available in 1629 nulliparous women who were randomly assigned at 13 to 27 weeks to receive 60 mg/day aspirin or a placebo. A total of 891 (55%) received epidural anesthesia, and the remaining 738 did not. RESULTS: Among the 891 women known to have received epidural anesthesia, 451 were assigned to low-dose aspirin and 440 to placebo. There was no instance of bleeding related to epidural use. In addition, there were no differences in maternal and neonatal complications between those receiving or not receiving epidural anesthesia. Within the group receiving epidural anesthesia there were no differences in bleeding complications between those assigned to aspirin on placebo. One of the five centers also obtained bleeding times in 303 women (149 received aspirin and 154 received placebo). The mean +/- SD bleeding time in women assigned to low-dose aspirin was significantly higher than in women assigned to placebo (6.99 +/- 2.95 minutes vs 5.99 +/- 2.43 minutes, p = 0.004). In addition, the frequency of women having a bleeding time > 10 minutes was higher in the aspirin group (14.1% vs 5.2%, p = 0.01). Interestingly, women who received an epidural anesthetic had a lower bleeding time than those not receiving an epidural (p = 0.003), irrespective of the treatment used. CONCLUSIONS: In women assigned to low-dose aspirin there were no adverse effects related to epidural anesthesia. In spite of an increased bleeding time in a subset of pregnant women assigned to low-dose aspirin, maternal-neonatal bleeding complications were not increased.

Analysis of Variance↗

Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers.

BACKGROUND: After endoscopic treatment of bleeding peptic ulcers, bleeding recurs in 15 to 20 percent of patients. METHODS: We assessed whether the use of a high dose of a proton-pump inhibitor would reduce the frequency of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. Patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels were treated with an epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned in a double-blind fashion to receive omeprazole (given as a bolus intravenous injection of 80 mg followed by an infusion of 8 mg per hour for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary end point was recurrent bleeding within 30 days after endoscopy. RESULTS: We enrolled 240 patients, 120 in each group. Bleeding recurred within 30 days in 8 patients (6.7 percent) in the omeprazole group, as compared with 27 (22.5 percent) in the placebo group (hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred during the first three days, which made up the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Three patients in the omeprazole group and nine in the placebo group underwent surgery (P=0.14). Five patients (4.2 percent) in the omeprazole group and 12 (10 percent) in the placebo group died within 30 days after endoscopy (P=0.13). CONCLUSIONS: After endoscopic treatment of bleeding peptic ulcers, a high-dose infusion of omeprazole substantially reduces the risk of recurrent bleeding.

Aged↗

Acute venous thromboembolism in patients with recent major bleeding. The influence of the site of bleeding and the time elapsed on outcome.

BACKGROUND: Patients with major bleeding who subsequently develop clinically apparent venous thromboembolism (VTE) present a particularly difficult therapeutic dilemma. METHODS: RIETE is a prospective registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. We retrospectively studied those who had experienced recent major bleeding (<30 days prior to VTE) to assess the influence of the site of bleeding and the time elapsed to VTE on their 3 month outcome. RESULTS: Of 12,294 patients enrolled up to July 2005, 306 (2.5%) had recent major bleeding: gastrointestinal (GI) tract, 116 (38%); intracranial, 94 (31%); other, 96 (31%). During the study period, 19 patients [6.2%; 95% confidence interval (CI) 3.5-8.9] with recent bleeding rebled (eight died): 13 of them (68%) during the first 2 weeks. Multivariate analysis confirmed that patients with recent GI bleeding had an increased risk for both major rebleeding (hazard ratio 2.8; 95% CI 1.4-5.3) and death (hazard ratio 1.9; 95% CI 1.2-3.1) compared to those with no recent bleeding. Those who bled in other sites had an increased risk only for death (hazard ratio 2.0; 95% CI 1.2-3.3). An elapsed time of <2 weeks from bleeding to the index VTE event was also associated with an increased risk for major rebleeding (hazard ratio 2.4; 95% CI 1.2-5.0) and death (hazard ratio 2.8; 95% CI 1.8-4.5). CONCLUSION: The incidence of new bleeding or death depends on the site of prior bleeding and the time elapsed until VTE. This information may help to identify the best therapeutic approach for these high-risk patients.

Acute Disease↗

The use of indium-111-labelled platelets for scintigraphic localization of gastrointestinal bleeding, with special reference to occult bleeding.

Gamma-camera imaging of the abdomen after injection of autologous 111In-labelled platelets was applied for localization of gastrointestinal bleeding in a study of 22 patients. In 15 studies showing scintigraphic signs of bleeding, the clinical presentation included occult bleeding in 6, melaena in 4, and bloody stools in 5. Scintigraphy could be done repeatedly for up to 1 week after a single tracer injection. The time interval between the injection and scintigraphic visualization of bleeding ranged from 10 min to 68 h, being longest in cases of occult bleeding. In most cases the scintigraphic findings were supported by other diagnostic modalities, including surgical removal of presumed sources of bleeding. In seven studies without scintigraphic signs of bleeding a probable source of bleeding was identified by other means in one patient. The 111In-platelet method seems to be a promising method for localization of gastrointestinal bleeding which may prove particularly useful in cases of occult or recurrent bleeding.

Adolescent↗

Relationship of first-trimester subchorionic bleeding detected by color Doppler ultrasound to subchorionic fluid, clinical bleeding, and pregnancy outcome.

We analyzed retrospectively the incidence of subchorionic fluid and embryonic death in 2116 consecutive patients evaluated with abdominal ultrasound and 783 patients evaluated with vaginal ultrasound. These women were examined during the first 12 postmenstrual weeks and had conceived as a result of infertility treatment. In addition, we analyzed the relationship of subchorionic bleeding to subchorionic fluid in 230 patients evaluated with color Doppler ultrasound and the relationship of subchorionic bleeding to clinical bleeding, precipitating factors, pregnancy outcome, and the karyotypes of abortuses. In single gestational sac pregnancies, subchorionic fluid was found equally often in women scanned with vaginal or color Doppler ultrasound, and less often with abdominal ultrasound (P less than .0001). Embryonic death was increased only in patients with large amounts of subchorionic fluid observed on abdominal ultrasound. Color Doppler ultrasound revealed subchorionic bleeding in 87 of 235 ultrasound scans (37%) and in 48 of 102 patients (47%) when subchorionic fluid was present. Subchorionic bleeding was associated with moderate or large amounts of subchorionic fluid (P = .041), with precipitating events (P less than .0001), and with clinical bleeding (P = .001). It was occult in ten of 48 patients (21%). Embryonic death occurred equally often in women with no fluid and in those with subchorionic fluid, with and without subchorionic bleeding. Abortuses were karyotypically abnormal in an equal proportion of cases with subchorionic bleeding, subchorionic fluid, and no fluid. These findings indicate that subchorionic fluid and subchorionic bleeding are common findings in early pregnancy and are not associated with embryonic death unless they are accompanied by clinical bleeding.

Female↗

Non-occlusive bleeding times may improve the value of Ivy bleeding times.

The present studies measured bleeding times, without venous occlusion, in a series of patients, whose bleeding times (+ venostasis) consistently exceeded 20 min. During these tests, the amount of blood loss (expressed as mg/min) was also quantitated. To allow comparison, normal controls were studied before and following aspirin ingestion. In normal controls, the mean standard Ivy bleeding time was 5.0 with a range of 2.5 to 7.5 min. Two hours after aspirin (650 mg), this increased to 7.3 min (range 4.0-12.0). For comparison, the non-occlusive bleeding time averaged 3.8 min (1.0-6.5) and after aspirin 5.3 min (2.5-11.5). The measured amount of blood loss was 5.0 mg/min (0-10.5 mg/min) under all of the above conditions. At the other extreme, patients with severe bone marrow failure had occluded and non-occluded bleeding times in excess of 20 min. Moreover, these were often associated with excess blood loss. By contrast, patients with "Ivy" values greater than 20 min in association with platelet counts greater than 10,000/microliters had unpredictable bleeding parameters. In the latter group, the non-occluded values ranged from 1 to greater than 20 min. Of particular note, the non-occlusive times appeared to correlate with spontaneous bleeding manifestations. Only a rare patient (1/37), whose non-occluded value was less than 20 min, had worrisome bleeding. By contrast, serious bleeding manifestations were observed in 39% whose non-occluded value exceeded 20 min. This was even higher (64%) in those with a non-occluded value greater than 20 min and excess blood loss.(ABSTRACT TRUNCATED AT 250 WORDS)

Arm↗

The bleeding severity index: validation and comparison to other methods for classifying bleeding complications of medical therapy.

Reports of bleeding complications of medical therapy should be based on valid methods of classification, but the reproducibility of existing methods has not been tested. Therefore, we prospectively studied three methods to classify the severity of bleeding: a purely subjective implicit method, a previously published explicit method using brief criteria, and the bleeding severity index, which is a new explicit method using detailed criteria about the amount, rate, and consequences of bleeding. Three physicians independently reviewed abstracts of 168 patients treated with anticoagulants. The proportion of cases classified as major bleeding varied widely when the implicit method was used (2, 14 and 39%), less when the old explicit method was used (28, 40 and 47%), and not at all when the new bleeding severity index was used (20, 20 and 20%). Intraobserver agreement was excellent for both explicit methods (kappa greater than or equal to 0.95). However, interobserver agreement was better for the bleeding severity index (kappa = 0.87) than for the old explicit method (kappa = 0.69) or the implicit method (kappa = 0.39). We conclude that the classification of bleeding complications of medical therapy depends on the method used. In comparison to older methods, the bleeding severity index is highly reproducible and should be tested more widely to determine whether it can be applied to the burgeoning clinical research in anticoagulation and thrombolysis.

Anticoagulants↗