Severity Of Bleeding Complications Research Articles

Thrombotic and Bleeding Complications in Patients with Chronic Lymphocytic Leukemia and Severe COVID-19: A Study of Eric, the European Research Initiative on CLL

Background: Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to COVID-19 related poor outcomes, including thrombosis and death, due to the advanced age, the presence of comorbidities, and the disease and treatment-related immune deficiency. The aim of this study was to assess the risk of thrombosis and bleeding in patients with CLL affected by severe COVID-19. Methods: This is a retrospective multicenter study conducted by ERIC, the European Research Initiative on CLL, including patients from 79 centers across 22 countries. Data collection was conducted between April and May 2021. The COVID-19 diagnosis was confirmed by the real-time polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 on nasal or pharyngeal swabs. Severe cases of COVID-19 were defined by hospitalization and the need of oxygen or admission into ICU. Development and type of thrombotic events, presence and severity of bleeding complications were reported during treatment for COVID-19. Bleeding events were classified using ISTH definition. STROBE recommendations were used in order to enhance reporting. Results: A total of 793 patients from 79 centers were included in the study with 593 being hospitalized (74.8%). Among these, 511 were defined as having severe COVID: 162 were admitted to the ICU while 349 received oxygen supplementation outside the ICU. Most patients (90.5%) were receiving thromboprophylaxis. During COVID-19 treatment, 11.1% developed a thromboembolic event, while 5.0% experienced bleeding. Thrombosis developed in 21.6% of patients who were not receiving thromboprophylaxis, in contrast to 10.6% of patients who were on thromboprophylaxis. Bleeding episodes were more frequent in patients receiving intermediate/therapeutic versus prophylactic doses of low-molecular-weight heparin (LWMH) (8.1% vs. 3.8%, respectively) and in elderly. In multivariate analysis, peak D-dimer level and C-reactive protein to albumin ratio were poor prognostic factors for thrombosis occurrence (OR=1.022, 95%CI 1.007‒1.038 and OR=1.025, 95%CI 1.001‒1.051, respectively), while thromboprophylaxis use was protective (OR=0.199, 95%CI 0.061‒0.645). Age and LMWH intermediate/therapeutic dose administration were prognostic factors in multivariate model for bleeding (OR=1.062, 95%CI 1.017-1.109 and OR=2.438, 95%CI 1.023-5.813, respectively). Conclusions: Patients with CLL affected by severe COVID-19 are at a high risk of thrombosis if thromboprophylaxis is not used, but also at increased risk of bleeding under the LMWH intermediate/therapeutic dose administration. Paolo Ghiaand Kostas Stamatopoulos contributed equally to this work.

Thrombotic and bleeding complications in patients with chronic lymphocytic leukemia and severe COVID-19: a study of ERIC, the European Research Initiative on CLL

BackgroundPatients with chronic lymphocytic leukemia (CLL) may be more susceptible to COVID-19 related poor outcomes, including thrombosis and death, due to the advanced age, the presence of comorbidities, and the disease and treatment-related immune deficiency. The aim of this study was to assess the risk of thrombosis and bleeding in patients with CLL affected by severe COVID-19.MethodsThis is a retrospective multicenter study conducted by ERIC, the European Research Initiative on CLL, including patients from 79 centers across 22 countries. Data collection was conducted between April and May 2021. The COVID-19 diagnosis was confirmed by the real-time polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 on nasal or pharyngeal swabs. Severe cases of COVID-19 were defined by hospitalization and the need of oxygen or admission into ICU. Development and type of thrombotic events, presence and severity of bleeding complications were reported during treatment for COVID-19. Bleeding events were classified using ISTH definition. STROBE recommendations were used in order to enhance reporting.ResultsA total of 793 patients from 79 centers were included in the study with 593 being hospitalized (74.8%). Among these, 511 were defined as having severe COVID: 162 were admitted to the ICU while 349 received oxygen supplementation outside the ICU. Most patients (90.5%) were receiving thromboprophylaxis. During COVID-19 treatment, 11.1% developed a thromboembolic event, while 5.0% experienced bleeding. Thrombosis developed in 21.6% of patients who were not receiving thromboprophylaxis, in contrast to 10.6% of patients who were on thromboprophylaxis. Bleeding episodes were more frequent in patients receiving intermediate/therapeutic versus prophylactic doses of low-molecular-weight heparin (LWMH) (8.1% vs. 3.8%, respectively) and in elderly. In multivariate analysis, peak D-dimer level and C-reactive protein to albumin ratio were poor prognostic factors for thrombosis occurrence (OR = 1.022, 95%CI 1.007‒1.038 and OR = 1.025, 95%CI 1.001‒1.051, respectively), while thromboprophylaxis use was protective (OR = 0.199, 95%CI 0.061‒0.645). Age and LMWH intermediate/therapeutic dose administration were prognostic factors in multivariate model for bleeding (OR = 1.062, 95%CI 1.017–1.109 and OR = 2.438, 95%CI 1.023–5.813, respectively).ConclusionsPatients with CLL affected by severe COVID-19 are at a high risk of thrombosis if thromboprophylaxis is not used, but also at increased risk of bleeding under the LMWH intermediate/therapeutic dose administration.

Optimization of Surgical Time Through the Implementation of a Rational Protocol to Prevent Bleeding in Sleeve Gastrectomy.

Introduction: Staple line oversewing (SLO) is a prophylactic alternative due to its low cost and its effect of decreasing the incidence and severity of bleeding complications in sleeve gastrectomy (SG). However, this approach significantly increases the surgical time and may be associated with stenosis. The study aims to identify whether its usage was sufficient to optimize the surgical time in patients whose screening for the risk of occult bleeding was negative. Materials and Methods: The study enrolled 103 patients. Having the systolic blood pressure goal of 140 mmHg, the staple line is checked for bleeding points, counting as follows: >5 bleeding points proceed to SLO, <5 bleeding points are managed using clips, and if no bleeding points are found, the procedure can be completed. Results: The bleeding test was positive in 79.6% of the cases and oversewing was necessary for 44.7% of the total. The bleeding test result was significant for the increased surgical time. The mean surgical time in SLO was 16.4% higher than in clipping. There was a significant difference in surgical time between SLO and clipping; however, no significant difference was identified between clipping and continuing the procedure without further measures. No postoperative complication related to staple line bleeding was identified. Discussion: In a scenario with limitations for the use of high-cost homeostatic agents, the stratified protocol to prevent bleeding in SG stapling line was able to significantly reduce surgical time without significant added risks. Conclusion: A stratified protocol to prevent bleeding in SG stapling line was able to significantly reduce surgical time.

Prevalence and management of antivitamin K overdose in a hospital setting.

Vitamin K antagonist (VKA) related adverse events are the first cause for iatrogenic events in France, particularly due to the narrow therapeutic margin. The risk of bleeding increases significantly when the INR level is ≥5. The main objective of this study was to assess the prevalence of VKA overdose in a hospital setting (at D2 of hospital entry) and to evaluate physicians' adherence to clinical practice guidelines for the management of VKA overdose according to French National Authority for Health recommendations. This single-center retrospective observational study consisted in querying the computerized database of a Parisian hospital on 21275INR determinations (3995 patients, 6813 hospital stays) performed between 2013 and 2018. An INR level ≥5 was noted during 350 (6%) of the hospital stays, in 331 patients (of whom 57% were women). The mean age of the patient population with an INR≥5 was 81.1 years. Infection, heart failure and renal failure were the most frequent acute medical conditions for hospital admission. Twenty-three patients (7%) had a bleeding complication, 11 of which were major bleeding complications. Older age was associated with the severity of bleeding complications. Fifteen in-hospital deaths (4%) were reported, not related to bleeding events. The management of VKA overdose did not comply with the recommendations in 43% of cases, in particular for the highest INRs (50% of noncompliance for an INR>6.4). Non-compliance with recommendations for VKA overdose was related to: the delay until the INR was checked (44% of cases); the indication for prescribing vitamin K (34% of cases); the dose or route of administration of vitamin K therapy (19% of cases); and the interruption or not of VKA therapy (12% of cases). The management of VKA overdose in a hospital setting remains non-compliant with the recommendations in almost half of the cases, mainly due to the delayed INR control and inappropriate management of vitamin K therapy. Computerized alert system would be helpful for personalized patient management and improved pharmacovigilance to prevent iatrogenic VKA events.

Is it safe to continue antithrombotic agents before prostate biopsy?

BackgroundWhether antithrombotic agents should be stopped before prostate biopsy is unsettled. We investigated the impact of antithrombotic agents on bleeding complications after prostate biopsy.Materials and methodsAmong the patients who underwent transrectal ultrasound-guided prostate biopsy from June 2006 to December 2013 at Ebina General Hospital, Kanagawa, Japan, 1817 cases were retrospectively assessed. Patients were divided into two groups: those not taking antithrombotic agents (control group) and those taking them (experimental group). The frequency and severity of bleeding complications after the procedure were compared. The severity of bleeding events was graded using the Common Terminology Criteria for Advanced Events vol. 4.0.ResultsHemorrhagic complications were classified into grades 1 to 3. Patients with complications of Grade 2 and above needed treatment. As for the Grade 1 event, there were no differences between two groups. The frequency of more than Grade 2 bleeding events was 1.7% and 3.5% in the control and experimental group, respectively; the odds ratio was 2.18 (P = 0.039). Grade 3 events occurred in seven patients of the control group (0.5%) and four patients of the experimental group (1.2%).ConclusionsThe present study showed that continuation of antithrombotic agents increased the frequency of hemorrhagic complications requiring intervention. It suggests that attention should be paid to the patients taking antithrombotic agents before prostate biopsy.

Outcomes during anticoagulation in patients with symptomatic vs. incidental splanchnic vein thrombosis

IntroductionCurrent guidelines recommend the use of anticoagulant therapy in patients with symptomatic splanchnic vein thrombosis (SVT) and suggest no routine anticoagulation in those with incidental SVT. MethodsWe used the RIETE (Registro Informatizado Enfermedad Trombo Embólica) registry to assess the rate and severity of symptomatic venous thromboembolism (VTE) recurrences and major bleeding events appearing during the course of anticoagulation in patients with symptomatic or incidental SVT. ResultsIn March 2017, 521 patients with SVT were recruited. Of them, 212 (41%) presented with symptomatic SVT and 309 had incidental SVT. Most (93%) patients received anticoagulant therapy (median, 147 days). During the course of anticoagulation, 20 patients developed symptomatic VTE recurrences (none died) and 26 had major bleeding (fatal bleeding, 5). On multivariable analysis, patients with incidental SVT had a non-significantly higher risk for symptomatic VTE recurrences (adjusted hazard ratio [HR]: 2.04; 95%CI: 0.71–5.88) and a similar risk for major bleeding (HR: 1.12; 95%CI: 0.47–2.63) than those with symptomatic SVT. Active cancer was associated with at increased risk for VTE recurrences (HR: 3.06; 95%CI: 1.14–8.17) and anaemia (HR: 4.11; 95%CI: 1.45–11.6) or abnormal prothrombin time (HR: 4.10; 95%CI: 1.68–10.1) were associated with at increased risk for major bleeding. ConclusionsThe rates of recurrent SVT and major bleeding were similar between patients with incidental or symptomatic SVT. Because the severity of bleeding complications during anticoagulation may outweigh the severity of VTE recurrences in both groups, further studies should identify those SVT patients who benefit from anticoagulant therapy.

Differential diagnosis and therapeutic limitations in a rare case of acquired factor X deficiency

Acquired Factor X deficiency is a rare coagulation disorder, which predominantly presents with mucocutaneous bleeding, and is associated with systemic amyloid light-chain (AL) amyloidosis in the vast majority of cases. There are, however, rare case reports of its occurrence in the context of acute respiratory infection, various malignancies, and following exposure to certain medications. We report a case of an 82-year-old man who presented with a Non-ST segment elevation myocardial infarction, decompensated biventricular failure, Respiratory Syncytial Virus (RSV) pneumonia, active haemoptysis, and a profound coagulopathy. Initial laboratory studies were consistent with acquired isolated Factor X deficiency (prolonged Prothrombin Time and Activated Partial Thromboplastin Time, correction with mixing studies, factor X level < 3%), however Congo red staining for AL amyloidosis on abdominal fat biopsy was negative. The patient was acutely managed with prothrombinex therapy with partial but temporary reversal of their coagulopathy and resolution of their bleeding. Unfortunately, solid organ biopsy was deemed unsafe and the patient passed away from recurrent sepsis before a formal diagnosis of the underlying aetiology could be made. This article describes a diagnostic approach to coagulation factor deficiencies and AL amyloidosis, and their limitations in the coagulopathic patient. It further reviews the correlation between severity of bleeding complications and Factor X coagulant activity. Lastly, it outlines potential treatment options for acquired Factor X deficiency; such as coagulation factor replacement, plasma exchange, and targeted amyloidosis therapies.

Bleeding complications in cholecystectomy: a register study of over 22,000 cholecystectomies in Finland.

BackgroundMajor bleeding is rare but among the most serious complications of laparoscopic surgery. Still very little is known on bleeding complications and related blood component use in laparoscopic cholecystectomy (LC). The aim of this study is to compare bleeding complications, transfusion rates and related costs between LC and open cholecystectomy (OC).MethodsData concerning LCs and OCs and related blood component use between 2002 and 2007 were collected from existing computerized medical records (Finnish Red Cross Register) of ten Finnish hospital districts.ResultsRegister data included 17175 LCs and 4942 OCs. In the LC group, 1.3 % of the patients received red blood cell (RBC) transfusion compared to 13 % of the patients in the OC group (p < 0.001). Similarly, the proportions of patients with platelet (0.1 % vs. 1.2 %, p < 0.001) and fresh frozen plasma (FFP) products (0.5 % vs. 5.8 %) transfusions were respectively higher in the OC group than in the LC group. The mean transfused dose of RBCs, PTLs and FFP product Octaplas® or the mean cost of the transfused blood components did not differ significantly between the LC and OC groups.ConclusionsLaparoscopic cholecystectomy was associated with lower transfusion rates of blood components compared to open surgery. The severity of bleeding complications may not differ substantially between LC and OC.

Mo1010 Severity of Bleeding Complications in Cirrhotic Patients Compared to Non-Cirrhotic Patients Treated for Acute Myocardial Infarction

Mo1010 Severity of Bleeding Complications in Cirrhotic Patients Compared to Non-Cirrhotic Patients Treated for Acute Myocardial Infarction

Comparison of Dabigatran and Uninterrupted Warfarin in Patients With Atrial Fibrillation Undergoing Cardiac Rhythm Device Implantations

Background:The incidence of postoperative complications following pacemaker or implantable cardioverter-defibrillator implantations in patients treated with new oral anticoagulation agents has not been studied. Here we present a first comparison of complications after cardiac rhythm device (CRD) implantations in patients with atrial fibrillation (AF) treated with dabigatran or uninterrupted warfarin.Methods and Results:Using a case-control study design, we compared complications within 30 days after 236 CRD procedures performed under uninterrupted warfarin (n=118) or interrupted dabigatran (n=118).There were no significant differences in the baseline characteristics of both groups. In the warfarin group, 9 (8%) pocket hematomas were observed vs. 3 (3%) in the dabigatran group (P=0.075). Two complications in the warfarin group necessitated surgical intervention as opposed to none in the dabigatran group (P=0.156). The postprocedural blood loss expressed as a drop in hemoglobin was significantly greater in the warfarin group (-0.9±0.7 vs. -0.5±0.4 mmol/L, P=0.023). In the dabigatran group, 1 case of transient ischemic attack occurred. The mean time to hospital discharge was shorter in patients treated with dabigatran (2.5±2.3 vs. 3.8±4.1 days, P=0.02).Conclusions:The incidence and severity of bleeding complications may be lower in patients treated with periprocedurally discontinued dabigatran when compared with uninterrupted warfarin therapy. Further evaluation of peri-interventional complications and establishment of an optimal anticoagulation management protocol are needed.

Combination oral antiplatelet therapy may increase the risk of hemorrhagic complications in patients with acute ischemic stroke caused by large artery disease

Introduction The association between the frequency or severity of bleeding complications and combination antiplatelet therapy for acute stroke treatment is not understood in detail. This retrospective study investigated whether combination oral antiplatelet therapy for cases with acute ischemic stroke due to large artery disease increased the incidence of hemorrhagic complications. Materials and Methods We reviewed 1335 consecutive patients who were admitted to our department within 7 days of the onset of an ischemic stroke or transient ischemic attack between April 2005 and November 2009. We enrolled 167 patients with > 50% stenosis or occlusion in culprit major vessels and who were administered oral antiplatelet agents within 48 hours of admission. Hemorrhagic complications were classified according to the bleeding severity index. We studied the association between the incidence and severity of hemorrhagic complication s during hospitalization and the clinical characteristics, including antiplatelet therapy. Results Fifty-nine and 108 patients were treated with only 1 antiplatelet agent and combination antiplatelet agents, respectively. Fourteen patients developed bleeds (3 major and 11 minor), and all of the major bleeds occurred in those given combination agents. The proportion of patients receiving combination agents was significantly higher in those with significant bleeds. Multivariate logistic regression analysis revealed that being older and receiving combination agents were independent predictors for significant bleeds during hospitalization. Conclusions Despite the retrospective nature of this study, our findings suggest that the incidence of hemorrhagic complications increases in patients with acute ischemic stroke treated with combination antiplatelet agents.

Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: A proposal from the Academic Bleeding Consensus (ABC) Multidisciplinary Working Group

Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.

The balance between bleeding and ischaemic complications in percutnaeous coronary intervention practice

Strong antithrombotic treatments may decrease the risk of recurrent ischaemic events in patients with acute coronary syndromes (ACS) and, as adjunctive therapy to percutaneous coronary intervention (PCI), they have shown a strong clinical benefit. However, a significant decrease in the risk of ischaemic complications is invariably associated with an increased risk of bleeding and there is growing evidence that bleeding in patients with ACS has a strong impact on survival. 1 It is not easy to ascertain the true impact of bleeding on clinical outcome in patients undergoing PCI due to the need of large sample of patients to avoid the confounding effect of the worse baseline risk profile of patients who suffer bleeding, the need for an appropriate definition of the severity of bleeding complications, the confounding effect of many variables that are linked to bleeding and that are unexplored in most studies, such as the dose and duration of an antithrombotic treatment, the maintenance of femoral sheath in PCI patients after the procedure, the cut off of haematological parameters used for blood transfusion, the criteria used for discontinuation of antithrombotic treatment. Again, most of deaths are not directly due to a fatal bleeding, and the link between bleeding and mortality is not easily or fully explained in most studies, and the mechanism(s) of death remains largely speculative. The definition of major bleeding

Characteristics of bleeding complications in patients with anticoagulant treatment.

Anticoagulation treatment is effective in the prevention of stroke as well as deep venous thrombosis (DVT) and pulmonary embolism (PE). Its preventive benefit has to be balanced against possible bleeding complications. We sought to assess risk factors for the severity of bleeding events in patients under anticoagulant treatment. Clinical characteristics, type of anticoagulant treatment, bleeding site, risk factors and additional medication taken were analysed in patients with bleeding complications during an observation period of 12 months. Eighty-seven bleeding complications in 84 patients (mean age, 79 years; 51% female) were observed from January to December 2005 at the Department of Internal Medicine of the Cantonal Hospital of Aargau. Most bleeding complications occurred in the gastrointestinal tract (54%). The median time interval from the beginning of the anticoagulant treatment to the bleeding event was 34 months. Forty-nine percent of events occurred after a treatment time above 36 months. Age was not found to influence the severity of bleeding but the duration of anticoagulant treatment before the occurrence of a complication was significantly longer for older patients (p = 0.001). Our study shows no influence of age on severity of bleeding complications. Furthermore, in patients with advanced age complications occurred later in the treatment course than in younger patients. Overall we assessed various bleeding events in patients treated for over three years. Therefore we emphasize the importance of closely controlling patients on anticoagulant treatment in the later course of treatment and to take account of the anticoagulation when ordering new medication.

Characteristics of bleeding complications in patients with anticoagulant treatment.

Anticoagulation treatment is effective in the prevention of stroke as well as deep venous thrombosis (DVT) and pulmonary embolism (PE). Its preventive benefit has to be balanced against possible bleeding complications. We sought to assess risk factors for the severity of bleeding events in patients under anticoagulant treatment. Clinical characteristics, type of anticoagulant treatment, bleeding site, risk factors and additional medication taken were analysed in patients with bleeding complications during an observation period of 12 months. Eighty-seven bleeding complications in 84 patients (mean age, 79 years; 51% female) were observed from January to December 2005 at the Department of Internal Medicine of the Cantonal Hospital of Aargau. Most bleeding complications occurred in the gastrointestinal tract (54%). The median time interval from the beginning of the anticoagulant treatment to the bleeding event was 34 months. Forty-nine percent of events occurred after a treatment time above 36 months. Age was not found to influence the severity of bleeding but the duration of anticoagulant treatment before the occurrence of a complication was significantly longer for older patients (p = 0.001). Our study shows no influence of age on severity of bleeding complications. Furthermore, in patients with advanced age complications occurred later in the treatment course than in younger patients. Overall we assessed various bleeding events in patients treated for over three years. Therefore we emphasize the importance of closely controlling patients on anticoagulant treatment in the later course of treatment and to take account of the anticoagulation when ordering new medication.

Haemorrhagic Complications of Vitamin K Antagonists in the Elderly

In patients >75 years of age, the two main indications for oral anticoagulant therapy with vitamin K antagonists (VKAs) are treatment of venous thromboembolic disease and prevention of systemic embolism in patients with nonvalvular atrial fibrillation. In both indications, a target International Normalized Ratio of 2.5 (range 2.0-3.0) is recommended. Bleeding is the adverse effect feared by physicians that most limits the use of VKAs in older frail patients. In this paper, we discuss (i) the risk of VKA-related bleeding with advancing age; (ii) the severity of bleeding complications and particularly the risk of intracranial haemorrhage in older patients; (iii) the risk factors for bleeding related to patient characteristics; and (iv) the risk factors or determinants for bleeding related to treatment variables (warfarin induction and maintenance administration, instability of anticoagulation, poor compliance and patient's education level, and concomitant use of drugs). Avoiding over-anticoagulation and/or reducing periods of overdosing in the course of oral anticoagulant treatment with tailored monitoring may help to minimise the risk of bleeding in older patients.

Biopsy of the prostate guided by transrectal ultrasound: relation between warfarin use and incidence of bleeding complications

To determine the relation between warfarin use and the frequency of bleeding complications after biopsy of the prostate guided by transrectal ultrasound (TRUS). Overall, 1022 consecutive patients with suspected prostatic disease were followed after biopsy. Warfarin and aspirin use was determined on the day of the procedure. A TRUS-guided biopsy was performed and patients were offered a questionnaire to complete 10 days after the procedure, to determine any immediate or delayed bleeding complications. Follow-up telephone calls were made to those who had not replied within the stipulated period. Of the 1000 patients who replied, 49 were receiving warfarin, 220 were receiving aspirin and 731 were not receiving any anticoagulant drugs. Of the 49 subjects reporting current use of warfarin, 18 (36.7%) experienced haematuria, compared with 440 (60.2%) of the patients receiving no anti-coagulant drugs who reported haematuria. This was statistically significant (p = 0.001). Of the group receiving warfarin, 4 (8.2%) experienced haematospermia whereas 153 (21%) of the group receiving no anticoagulant medication reported haematospermia. This difference also was statistically significant (p = 0.030). Rectal bleeding was experienced by 7 (14.3%) of the group receiving warfarin compared with 95 (13%) in the group without anticoagulant medication, but this was not statistically significant (p = 0.80). We also demonstrated that there was no statistically significant association between the severity of the bleeding complications and medication with warfarin. None of the group receiving warfarin experienced clinically important bleeding complications. Our results suggest that the frequency and severity of bleeding complications were no worse in the warfarin group than in the control group and that discontinuing anticoagulation medication before prostate biopsy may be unnecessary.

Thrombocytopenia in patients receiving oral anticoagulant therapy.

The aim of this report was to determine the frequency of thrombocytopenia in a cohort of 1,126 patients receiving oral anticoagulant therapy (OAT), and to compare the grade of thrombocytopenia and the severity of bleeding complications. Severe thrombocytopenia was observed in five patients, and moderate and light thrombocytopenia were observed in 208 patients. Thrombocytopenic patients receiving OAT presented five major and six minor hemorrhages. The presence of hepatitis markers and autoantibodies was assessed. All parameters at the time of the bleeding complication were in the therapeutic range.

The risk for and severity of bleeding complications in elderly patients treated with warfarin. The National Consortium of Anticoagulation Clinics.

To determine whether increasing age is associated with an increased risk for bleeding during warfarin treatment. Combined retrospective and prospective cohort studies. 6 anticoagulation clinics. 2376 patients receiving warfarin for various indications. Bleeding events categorized as minor (resulting in no costs or consequences), serious (requiring testing or treatment), life-threatening, or fatal. 812 first bleeding events (4 fatal, 33 life-threatening, 222 serious, and 553 minor) occurred during 3702 patient-years. Age was inversely related to the mean warfarin dose and dose-adjusted prothrombin time ratio. The unadjusted incidence of minor bleeding complications did not vary according to age group: 18.0 per 100 patient-years for patients younger than 50 years of age, 21.5 for patients 50 to 59 years of age, 24.0 for patients 60 to 69 years of age; 23.5 for patients 70 to 79 years of age, and 16.3 for patient 80 years of age and older. The unadjusted incidence of serious bleeding complications also did not vary according to age group: 9.3 per 100 patient-years for patients younger than 50 years of age, 7.1 for patients 50 to 59 years of age, 6.6 for patients 60 to 69 years of age, 5.1 for patients 70 to 79 years of age, and 4.4 for patients 80 years of age and older. The unadjusted incidence of life-threatening or fatal complications combined was significantly higher among the oldest patients: 0.75 per 100 patient-years for patients younger than 50 years of age, 0.97 for patients 50 to 59 years of age, 1.10 for patients 60 to 69 years of age, 0.68 for patients 70 to 79 years of age, and 3.38 for patients 80 years of age and older. Patients 80 years of age and older had a relative risk of 4.5 (95% CI, 1.3 to 15.6) compared with patients younger than 50 years of age. After adjustment for the intensity of anticoagulation therapy and the deviation in the prothrombin time ratio using Cox and Poisson regression, age was not generally associated with the occurrence of bleeding; relative risk estimates ranged from 0.99 to 1.03 per year of age (lower-bound 95% CI, 0.97 to 1.01; upper-bound 95% CI, 1.00 to 1.09). The single exception was life-threatening and fatal complications in patients 80 years of age or older (relative risk, 4.6 [CI, 1.2 to 18.1]). Age did not appear to be an important determinant of risk for bleeding in patients receiving warfarin, with the possible exception of age 80 years or older. The intensity of anticoagulation therapy and the deviation in the prothrombin time ratio were much stronger predictors of risk for bleeding.

A randomized clinical trial of the effect of bed position after PTCA

After percutaneous transluminal coronary angioplasty, prolonged supine bedrest with the bed flat frequently causes back pain. This study was conducted to examine whether percutaneous transluminal coronary angioplasty patients could adjust their bed position to make themselves comfortable without increasing the frequency or severity of bleeding complications. To determine whether the risk of bleeding increased in patients who were allowed to use their bed controls to make themselves comfortable, and if the difference in comfort was significant between patients who controlled and elevated their bed position and patients who remained flat in bed. A randomized clinical trial was conducted; 54 patients undergoing percutaneous transluminal coronary angioplasty were randomly assigned to either the control group, in which patients remained flat in bed, or the experimental group, in which they controlled their bed position. Outcome measures included amount of bleeding at the catheter sites and patient comfort. No difference in the amount of bleeding at catheter insertion sites was found between the two groups. Few subjects reported pain at any time. Back pain at dinner and bedtime was higher in the control group, but only the bedtime difference was statistically significant. We conclude that patients may be allowed to adjust their bed position to 30 degrees for comfort without incurring increased risk of catheter entry site bleeding and that requiring patients to remain flat in bed has no scientific basis.