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PubMed2000

Measurement of the procoagulant activity of factor VII in patients with liver cirrhosis and normal prothrombin activity: evaluation of the bleeding risk.

Patients with liver cirrhosis and diminished prothrombin activity (PA) have decreased levels of factor (F)VII coagulation activity (FVII:C) and an increased bleeding tendency. Whether this is also true of cirrhotic patients with normal PA is unknown. This study measured FVII:C levels in such patients and investigated the correlation between altered FVII:C levels and bleeding tendency. Fifteen of 41 patients (37%) had decreased FVII:C levels. Of these, the Child-Pugh score of liver function was A (n = 9), B (n = 5) and C (n = 1), compared to A (n = 25) and B (n = 1) in patients with normal FVII:C values (chi2 = 8.88, P = 0.012). Bleeding time was significantly prolonged in 9/15 patients (60%) with impaired FVII:C activity, compared to 3/26 (12%) patients with normal FVII:C values (relative risk: 5.2, 95% CI: 1.7-16.6; P = 0.003). In conclusion, liver cirrhosis patients may show impaired FVII:C levels despite normal PA. In those with decreased FVII:C activity, prolonged bleeding time is hypothesized to arise from an alteration in platelet activation due to FVII deficiency and diminished platelet count. Bleeding risk should be evaluated, regardless of platelet count, before these patients are subjected to invasive diagnostic or surgical procedures.

Adult↗
PubMedDate not supplied

The nature and frequency of potential warfarin drug interactions that increase the risk of bleeding in patients with atrial fibrillation.

PURPOSE: To determine the frequency with which atrial fibrillation (AF) patients receiving warfarin are prescribed interacting drugs that could increase bleeding risks. METHODS: We retrospectively examined medical records for 704 Medicare beneficiaries > or = 65 years of age discharged from Kansas hospitals with AF. We identified all patients receiving warfarin and examined discharge prescriptions for drugs that could increase bleeding risk either by increasing the international normalized ratio (INR) or directly inhibiting hemostasis. RESULTS: Of 256 patients discharged on warfarin, 138 (54%) were prescribed another medication that could increase bleeding risk. Among these patients, 106 (41%) were discharged with a total of 150 prescriptions for drugs that could interact with warfarin to increase the INR. Antibiotics accounted for 67% of these prescriptions. Fifty-three patients (21%) received 56 prescriptions for drugs which could inhibit hemostasis. These were primarily antiplatelet drugs with 61% of the prescriptions for aspirin. Patients with coronary artery disease were more likely than others to be prescribed warfarin plus antiplatelet agents (OR = 2.80; p = 0.04). More than one interacting drug was prescribed for 20% of the patients. CONCLUSIONS: AF patients discharged on warfarin were frequently prescribed concomitant medications that increase bleeding risks. These patients should be closely monitored and counseled to watch for signs of bleeding.

Aged↗
PubMed2006

The vital threat of an upper gastrointestinal bleeding: Risk factor analysis of 121 consecutive patients.

AIM: To analyze the importance in predicting patients risk of mortality due to upper gastrointestinal (UGI) bleeding under today's therapeutic regimen. METHODS: From 1998 to 2001, 121 patients with the diagnosis of UGI bleeding were treated in our hospital. Based on the patients' data, a retrospective multivariate data analysis with initially more than 270 single factors was performed. Subsequently, the following potential risk factors underwent a logistic regression analysis: age, gender, initial hemoglobin, coumarines, liver cirrhosis, prothrombin time (PT), gastric ulcer (small curvature), duodenal ulcer (bulbus back wall), Forrest classification, vascular stump, variceal bleeding, Mallory-Weiss syndrome, RBC substitution, recurrent bleeding, conservative and surgical therapy. RESULTS: Seventy male (58%) and 51 female (42%) patients with a median age of 70 (range: 21-96) years were treated. Their in-hospital mortality was 14%. While 12% (11/91) of the patients died after conservative therapy, 20% (6/30) died after undergoing surgical therapy. UGI bleeding occurred due to duodenal ulcer (n = 36; 30%), gastric ulcer (n = 35; 29%), esophageal varicosis (n = 12; 10%), Mallory-Weiss syndrome (n = 8; 7%), erosive lesions of the mucosa (n = 20; 17%), cancer (n = 5; 4%), coagulopathy (n = 4; 3%), lymphoma (n = 2; 2%), benign tumor (n = 2; 2%) and unknown reason (n = 1; 1%). A logistic regression analysis of all aforementioned factors revealed that liver cirrhosis and duodenal ulcer (bulbus back wall) were associated risk factors for a fatal course after UGI bleeding. Prior to endoscopy, only liver cirrhosis was an assessable risk factor. Thereafter, liver cirrhosis, the location of a bleeding ulcer (bulbus back wall) and patients' gender (male) were of prognostic importance for the clinical outcome (mortality) of patients with a bleeding ulcer. CONCLUSION: Most prognostic parameters used in clinical routine today are not reliable enough in predicting a patient's vital threat posed by an UGI bleeding. Liver cirrhosis, on the other hand, is significantly more frequently associated with an increased risk to die after bleeding of an ulcer located at the posterior duodenal wall.

Adult↗
PubMed2004

Relationship between platelet count and bleeding risk in thrombocytopenic patients.

Platelets are lost from circulation by 2 mechanisms: senescence and random loss. Approximately 7.1 x 10(3) platelets/microL/d are postulated to be randomly used in maintaining vascular integrity. Thus, in clinically stable patients, major bleeding is unusual unless the platelet count is </=5 x 10(3)/microL. Risk factors for bleeding at higher platelet counts are disseminated intravascular coagulation with contributory clotting factor deficiencies, structural lesions with loss of vascular integrity, and refractoriness to platelet transfusions. Several large studies have documented the safety of lowering the prophylactic platelet transfusion trigger from the previously used 20 x 10(3)/microL to 10 x 10(3)/microL. A few studies have even suggested that a 5 x 10(3)/microL trigger is acceptable. Based on these results, the next step of giving just therapeutic platelet transfusions is being evaluated. In a large retrospective study, the most significant predictor of bleeding was not the patient's platelet count but a history of bleeding in the prior 5 days. These data suggest that attention should be focused on providing aggressive platelet therapy for active bleeding rather than transfusing platelets prophylactically. Therapeutic platelet transfusions have been documented to control bleeding, and mortality rates are not increased when comparing patients receiving therapeutic to that seen in patients receiving prophylactic platelet transfusions.

Clinical Trials as Topic↗
PubMed2004

Addition of a second endoscopic treatment following epinephrine injection improves outcome in high-risk bleeding ulcers.

BACKGROUND & AIMS: Endoscopic therapy reduces the rebleeding rate, the need for surgery, and the mortality in patients with peptic ulcer and active bleeding or visible vessel. Injection of epinephrine is the most popular therapeutic method. Guidelines disagree on the need for a second hemostatic procedure immediately after epinephrine; although it seems to reduce further bleeding, its effects on morbidity, surgery rates, and mortality remain unclear. The aim of this study was to perform a systematic review and meta-analysis to determine whether the addition of a second procedure improves hemostatic efficacy and/or patient outcomes after epinephrine injection. METHODS: An extensive search for randomized trials comparing epinephrine alone vs. epinephrine plus a second method was performed in MEDLINE and EMBASE and in the abstracts of the AGA Congresses between 1990 and 2002. Selected articles were included in a meta-analysis. RESULTS: Sixteen studies including 1673 patients met inclusion criteria. Adding a second procedure reduced the further bleeding rate from 18.4% to 10.6% (Peto odds ratio 0.53, 95% CI: 0.40-0.69) and emergency surgery from 11.3% to 7.6% (OR: 0.64, 95% CI: 0.46-0.90). Mortality fell from 5.1% to 2.6% (OR: 0.51, 95% CI: 0.31-0.84). Subanalysis showed that the risk of further bleeding decreased regardless of which second procedure was applied. In addition, the risk was reduced in all subgroups, although reduction was more evident in high-risk patients and when no scheduled follow-up endoscopies were performed. CONCLUSIONS: Additional endoscopic treatment after epinephrine injection reduces further bleeding, need for surgery, and mortality in patients with bleeding peptic ulcer.

Epinephrine↗
PubMed1996

Conformal irradiation of the prostate: estimating long-term rectal bleeding risk using dose-volume histograms.

PURPOSE: Dose-volume histograms (DVHs) may be very useful tools for estimating probability of normal tissue complications (NTCP), but there is not yet an agreed upon method for their analysis. This study introduces a statistical method of aggregating and analyzing primary data from DVHs and associated outcomes. It explores the dose-volume relationship for NTCP of the rectum, using long-term data on rectal wall bleeding following prostatic irradiation. METHODS AND MATERIALS: Previously published data were reviewed and updated on 41 patients with Stages T3 and T4 prostatic carcinoma treated with photons followed by perineal proton boost, including dose-volume histograms (DVHs) of each patient's anterior rectal wall and data on the occurrence of postirradiation rectal bleeding (minimum FU > 4 years). Logistic regression was used to test whether some individual combination of dose and volume irradiated might best separate the DVHs into categories of high or low risk for rectal bleeding. Further analysis explored whether a group of such dose-volume combinations might be superior in predicting complication risk. These results were compared with results of the "critical volume model," a mathematical model based on assumptions of underlying radiobiological interactions. RESULTS: Ten of the 128 tested dose-volume combinations proved to be "statistically significant combinations" (SSCs) distinguishing between bleeders (14 out of 41) and nonbleeders (27 out of 41), ranging contiguously between 60 CGE (Cobalt Gray Equivalent) to 70% of the anterior rectal wall and 75 CGE to 30%. Calculated odds ratios for each SSC were not significantly different across the individual SSCs; however, analysis combining SSCs allowed segregation of DVHs into three risk groups: low, moderate, and high. Estimates of probabilities of normal tissue complications (NTCPs) based on these risk groups correlated strongly with observed data (p = 0.003) and with biomathematical model-generated NTCPs. CONCLUSIONS: There is a dose-volume relationship for rectal mucosal bleeding in the region between 60 and 75 CGE; therefore, efforts to spare rectal wall volume using improved treatment planning and delivery techniques are important. Stratifying dose-volume histograms (DVHs) into risk groups, as done in this study, represents a useful means of analyzing empirical data as a function of hetereogeneous dose distributions. Modeling efforts may extend these results to more heterogeneous treatment techniques. Such analysis of DVH data may allow practicing clinicians to better assess the risk of various treatments, fields, or doses, when caring for an individual patient.

Dose-Response Relationship, Radiation↗
PubMed1986

Hemodialysis using gabexate mesilate (FOY) in patients with a high bleeding risk.

The efficacy of gabexate mesilate (FOY), a synthetic serine proteinase inhibitor, was compared with that of heparin in preventing the acceleration of bleeding after hemodialysis. Transfused blood volume (TBV) was measured 24 h before and after 24 dialyses in 14 bleeding patients with impaired hemostatic function. The predialysis TBV did not differ significantly between heparin and FOY groups; however, TBV was significantly (p less than .05) larger after heparin dialysis than after FOY dialysis. After dialysis, TBV was increased in eight of nine heparin patients, compared to only three of 15 FOY subjects (p less than .01). FOY is an effective agent and may decrease postdialysis bleeding complications in certain high-risk patients.

Acute Kidney Injury↗
PubMed2006

Severe acute lower gastrointestinal bleeding: risk factors for morbidity and mortality.

BACKGROUND: Many factors can cause morbidity and mortality in patients with severe acute lower gastrointestinal bleeding (LGIB). The objectives of this study are to analyze three aspects related to severe acute LGIB: (1) indications and prognostic factors for urgent surgery, (2) risk factors for morbidity and mortality, and (3) relapse rates. PATIENTS AND METHODS: A retrospective cohort was collected between 1985 and 2002 in a tertiary referral center. One hundred seventy-one patients with severe acute LGIB were reviewed (LGIB is defined as frank rectal bleeding either with a hematocrit decrease >/=10 points or when a transfusion of at least three units of concentrated red blood cells is needed). The main outcome measures are: (1) indications for urgent surgery and results, (2) morbidity and mortality, and (3) relapse. RESULTS: There were 158 (92%) stable patients, and in 61% of these, the bleeding was identified via colonoscopy. Bleeding was identified using urgent colonoscopy in a higher percentage of patients compared to delayed colonoscopy (68% versus 14%; p < 0.001). Urgent surgery was indicated in 24 (14%) patients, and the approach was peri-anal in 5 (21%) patients and abdominal in the rest. Local intestinal resection was performed on the 15 patients in which bleeding was identified, whereas a subtotal colectomy was performed on the remaining 4 patients. The presence of hypotension (p = 0.001; 35 versus 10%) and etiology of LGIB (p < 0.001) are prognostic factors of urgent surgery. Morbidity was 6.4%, and mortality was 4.7%. The only morbidity or mortality risk factors detected were the presence of associated comorbidities (p = 0.008) and the need for urgent surgery (p = 0.002). The most frequent etiology was diverticulosis (25%). After a mean follow-up of 132 +/- 75 months, bleeding relapsed in 30% of patients. CONCLUSIONS: It is difficult to predict which patients are going to need urgent surgery in severe acute LGIB; only the presence of hypotension on arrival at the emergency ward would lead us to suspect a negative outcome for the hemorrhage. In severe acute LGIB, morbidity and mortality is high, and this is mainly due to the high level of associated comorbidity and the need for urgent surgery. It is necessary for strict hemodynamic monitoring of the patients at risk if we want to improve outcomes. The bleeding relapse rate is high in LGIB, although generally, it is not severe.

Acute Disease↗
PubMed1999

The antithrombotic efficacy of the GP IIb/IIIa antagonist SR121787 is potentiated by antithrombin-dependent factor Xa inhibition without an increase in the bleeding risk in the rabbit.

Current antithrombotic therapy in acute coronary symptoms is only partially effective and exhibits bleeding complications. These experiments were designed to address the antithrombotic and hemorrhagic interactions of the novel glycoprotein (GP) IIb/IIIa antagonist SR121787 in combination with the indirect inhibitor of factor Xa, SR90107/ORG31540. Thrombogenesis was initiated by electrolytic injury of the intimal surface of the carotid artery, and thrombus formation was assessed by recording carotid blood flow and by measuring thrombus weight 45 min after electrical stimulation. SR121787 was an efficacious antithrombotic agent in this model (ED50 = 16.3+/-0.3 mg/kg, p.o.), whereas heparin (4.5 mg/kg, i.v.) and SR90107/ORG31540 [1 mg/kg (850 aXa anti-units/kg), i.v.] were only marginally effective (17 and 27% inhibition of carotid blood flow reduction, respectively). Coadministrations of heparin (4.5 mg/kg, i.v.) or SR90107/ORG31540 (0.5 mg/kg, i.v.) were found to potentiate the antithrombotic efficacy of threshold doses of SR121787 (5 or 10 mg/kg, p.o.). The enhancement of the antithrombotic efficacy of SR121787 by SR90107/ORG31540 was--contrary to the association of SR121787 with heparin--not accompanied by an increased blood loss from the incised rabbit ear. Coadministrations of heparin or SR90107/ORG31540 did not influence the ex vivo antiaggregatory activity of SR121787. SR121787 coadministration did not alter the systemic anticoagulant activities in heparin or SR90107/ORG31540-treated animals. These data suggest the potential for optimized antithrombotic treatment in acute coronary syndromes when a GP IIb/IIIa antagonist (SR121787) is combined with an antithrombin-dependent factor Xa inhibitor (SR90107/ORG31540).

Animals↗
PubMed2002

Randomized trial of normal saline solution injection versus bipolar electrocoagulation for treatment of patients with high-risk bleeding ulcers: is local tamponade enough?

BACKGROUND: Endoscopic injection of normal saline solution is reportedly an effective treatment for bleeding ulcers. If it is as effective as standard therapy, low cost, wide availability, and lack of injury would make saline solution injection an attractive option. METHODS: Patients with clinical evidence of major bleeding from an ulcer with active bleeding or a nonbleeding visible vessel were randomly assigned to injection with normal saline solution (1-2 mL boluses; mean volume 30 mL) or bipolar electrocoagulation (20 W, 10-sec applications; mean time 100 sec). Patients, those caring for patients, and those collecting data were blinded to therapy. RESULTS: Further bleeding occurred in 14 (29%) of 48 patients in the saline solution group versus 6 (12%) of 52 patients in the bipolar group (95% CI [2%, 33%]; p = 0.04). Significantly more units of blood were transfused in the saline solution group (median 2 units vs. 0 units; p = 0.01). Hospital days (median 4 vs. 3) and mortality (6% vs. 2%) were not significantly different in the 2 groups. Independent risk factors for further bleeding were saline solution injection (p = 0.02), units transfused before therapy (p = 0.02), and ulcer size (p = 0.03). CONCLUSION: Local tamponade with saline solution injection is less effective than bipolar electrocoagulation for the treatment of bleeding ulcers.

Double-Blind Method↗
PubMed2001

[Acquired factor V inhibitor: etiology, bleeding risk and therapeutic management with regard to three cases].

INTRODUCTION: Acquired factor V inhibitor is rare and clinical symptoms are quite variable. Bleeding is the leading symptom but some patients are asymptomatic. Several diseases or conditions are associated with factor V inhibitors. Various treatments have been attempted but randomized or prospective trials are not available. EXEGESIS: Here we report three cases of acquired factor V inhibitor. These reports highlight the clinical variability of this disorder. Pathogenesis and therapy with reference to the literature are discussed. CONCLUSION: Factor V inhibitors are rare and associated to several diseases or conditions. Pathogenesis is still unclear except in patients exposed to bovine thrombin. The majority of the cases developed after surgery. In a few cases there is an association to a malignant or autoimmune disease. Plasmapheresis and platelet transfusions might be the best treatment in case of severe bleeding. High-dose intravenous immunoglobulin infusions have been used successfully in some cases and we report here their efficacy in two cases.

Aged↗
PubMed2000

Bleeding risk and platelet transfusion refractoriness in patients with acute myelogenous leukemia who undergo autologous stem cell transplantation.

Therapy for acute myelogenous leukemia can be complicated by alloimmunization to histocompatibility antigens (HLA), with resultant refractoriness to platelet transfusions. Autologous peripheral blood or bone marrow stem cell transplantation (referred here collectively as 'autoBMT') is emerging as a standard consolidative strategy in acute myelogenous leukemia (AML). We had noted life-threatening bleeding associated with platelet transfusion refractoriness following autoBMT; we therefore retrospectively analyzed 39 AML patients for this complication following BMT. All patients received high-dose chemoradiotherapy, followed by infusion of allogeneic sibling donor (n = 12, alloBMT) or autologous (n = 27, autoBMT) stem cells. HLA alloimmunization was assessed if patients were suspected of immune refractoriness to random donor platelet transfusions. Within 100 days of stem cell infusion, one of three alloBMT and six of 12 autoBMT recipients tested were HLA alloimmunized (not statistically significant, NS). Five of six HLA alloimmunized autoBMT patients experienced delayed bleeding, which contributed to their demise while still in remission (P < 0.001). Increased platelet requirements in HLA alloimmunized autoBMT recipients were observed between days 61 and 100 post-BMT, at a median of 211 platelet transfusions vs 0 in non-alloimmunized autoBMT patients (P < 0.01) and 17 in alloBMT patients. Our data suggest that platelet transfusion refractoriness, when associated with HLA alloimmunization, is a risk factor for increased platelet transfusion requirements, delayed bleeding, and poor outcome following autoBMT for AML.

Adolescent↗
PubMed1999

Bleeding risk in unruptured and residual cerebral aneurysms--angiographic annual growth rate in nineteen patients.

Whether and when unruptured aneurysms or aneurysmal rests following incomplete surgery result in subsequent bleeding are major concerns for neurosurgeons. By calculating the annual growth rate of aneurysms in long-term follow-up angiography (partly supplemented with MR-imaging and/or MR-angiography), we attempted to determine the surgical indications for these aneurysms. Long-term follow-up angiography ranging from one to 20 years was carried out on five patients whose ruptured aneurysms had been incompletely occluded, six patients with multiple aneurysms, of which the ruptured ones had been completely obliterated at operation and the small unruptured aneurysms, missed or misdiagnosed, and eight patients with unruptured aneurysms which were asymptomatic or symptomatic. The correlation of annual aneurysm growth rate to subsequent bleeding was investigated. Four out of six fast-growing aneurysms with high annual growth rates (more than 8% increase per year) resulted in subsequent bleeding whereas none of the fourteen slow-growing aneurysms with low annual growth rates (less than 8% increase per year) led to bleeding (Fisher's exact test; p < 0.01). Hypertension, patient age and aneurysmal location showed no significant correlation to the annual growth rate (Fisher's exact test; p > 0.05). This study suggests that aneurysmal rests after incomplete surgery and missed or misdiagnosed multiple or incidental aneurysms which are fast growing have a high possibility of subsequent bleeding and should be operated on as soon as possible.

Aneurysm, Ruptured↗
PubMed1995

[Endoscopic emergency therapy and early elective operation of at risk bleeding types in gastroduodenal ulcer hemorrhage--a prospective study].

253 consecutive patients with bleeding gastroduodenal ulcers were treated in a prospective protocol from Jan/1986 to Dec/1993. All underwent emergency endoscopy and injection therapy. In ulcers with a high risk of rebleeding (Forrest Ia, Ib, and IIvisible vessel) we performed an early elective operation (n = 126). Operative mortality was 9% (11/126). No patient died after endoscopic treatment, therefore the over-all mortality was 4% (11/253).

Aged↗
PubMed2001

Bleeding risk of tirofiban, a nonpeptide GPIIb/IIIa platelet receptor antagonist in progressive stroke: an open pilot study.

BACKGROUND: Glycoprotein (gp) IIb/IIIa-receptor antagonists are highly effective antiplatelet agents with proven efficacy in the treatment of acute coronary and experimental cerebral ischemia. In this study we examined the rate of hemorrhagic transformation and major bleedings in patients with acute stroke treated with tirofiban, a nonpeptide gpIIb/IIIa antagonist. METHODS: Eighteen patients with progressively deteriorating acute ischemic stroke were treated with body-weight adjusted intravenous tirofiban for a mean period of 46 h and compared with a matched group of 17 acute ischemic clinically stable stroke patients. Cerebral hemorrhage was assessed by cranial imaging 6-10 days after symptom onset. RESULTS: No major intracranial hemorrhage was observed in either group. Clinically asymptomatic hemorrhagic infarctions type I/II/III were detected in 4/2/0 controls and in 4/1/1 patients of the tirofiban group, respectively (OR = 0.92; 95% CI 0.4-2.5). Clinical outcome scores were not different in both groups (p = 0.18). CONCLUSIONS: Tirofiban was not associated with a significantly increased cerebral bleeding rate in acute ischemic stroke. Randomized multicenter studies are needed to further evaluate the safety and efficacy of tirofiban in the treatment of acute stroke.

Adult↗
PubMed2006

Background, rationale, and design of a clinical trial to assess the effects of platelet dose on bleeding risk in thrombocytopenic patients.

Outlined is the background and rationale for the initiation of a randomized prospective platelet transfusion trial to evaluate the effects of platelet dose on hemostasis and platelet utilization rates. This clinical trial is being performed by the newly established Transfusion Medicine/Hemostasis Clinical Trial Network supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The trial will randomize 1,350 patients into three platelet transfusion arms based on body surface area (BSA). The lower dose will be 1.1 x 10(11) platelets/m(2), the medium dose will be 2.2 x 10(11) platelets/m(2), and the higher dose will be 4.4 x 10(11) platelets/m(2). The primary outcome measure will be the incidence of Grade 2 bleeding; i.e., gross hemorrhage without the need for red cell transfusion. Major secondary outcome measures will be the total number of platelets transfused, the total number of platelet transfusion events, the highest grade of bleeding, and bleeding severity. It is expected that this clinical trial will change platelet transfusion practice by identifying whether low-dose platelet transfusion therapy provides adequate hemostasis and what is the most cost-effective strategy for providing platelet transfusions.

Clinical Protocols↗