Randomized controlled trial on the safety and efficacy of low molecular weight heparins in the prevention of thrombotic events in hospitalized cirrhotic patients - BEMI 2015

ANGELA PUENTE0 个研究点目标入组 225 人开始时间: 2016年2月3日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Applicants must meet all the following: 1) Liver cirrhosis of any etiology diagnosed
•by biopsy or after clinical, laboratory and ultrasound criteria; 2) Admission to
•hospital more than 3 days of their liver decompensation (ascites, encephalopathy,
•upper gastrointestinal bleeding or low controlled, spontaneous bacterial peritonitis)
•3) signed written consent.4) women in childbearing age with use of effective
•contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•One or more of the following: 1) Age <18 and> 80 years; 2) contraindication to
•heparin treatment of low molecular weight, 3) uncontrolled bleeding 4) Any
•comorbidity involving a therapeutic limitation and / or a life expectancy <6 months;
•5) concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole,
•sulfinpyrazone, dextran 40, or other anticoagulants 6) and continued concomitant
•NSAIDs, salicylates, corticosteroids; 7) existence of clinically significant esophageal
•varices / severe gastropathy of portal hypertension without their having been
•previously treated with primary / secondary prophylaxis (endoscopic variceal ligation
•/ non-cardioselective beta-blockers); 8) refusal to participate in the study or to sign
•the informed consent; 9) Pregnancy and lactation; 10) HIV infection; 11) severe
•thrombocytopenia <20,000 platelets / dl, 12) Failure to severe with lower clearance
•30ml / min Renal 13) portal vein thrombosis or peripheral thrombosis diagnosed on
•admission, 14) Presence of previously known procoagulant factor

发起方

ANGELA PUENTE