NCT02802605Unknown3 期
Randomized and Controlled Trial on the Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
Instituto de Investigación Marqués de Valdecilla0 个研究点目标入组 225 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 225
- 主要终点
- Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis.
研究概览
简要总结
Prospectively evaluation of the incidence of thromboembolic events in hospitalized cirrhotic patients. 2. Efficacy and safety of use of bemiparin in preventing peripheral and portal thrombosis. 3. Monitoring antiXa levels.
详细描述
PRIMARY OBJECTIVE: To evaluate the safety of prophylactic anticoagulation Bemiparina (HIBOR®) for the prevention of peripheral and portal vein thrombosis in cirrhotic patients with prolonged hospitalization.
Secondary objectives are the following:
- To evaluate the incidence of thrombotic events in hospitalized cirrhotic patients.
- To evaluate the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in hospitalized cirrhotic patients.
- To identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients.
- Evaluate the morbidity and mortality associated with thromboembolic events.
- Evaluate prophylactic anticoagulation levels by determining antiXa and antithrombin III.
- To study the expression profile and functionality of Toll-like receptors as factors intimately involved in the inflammatory response, as well as the variability of different serum markers associated with proinflammatory state: I-FABP / IL6-IL8 / NO, endothelin and LPS-binding protein.
- Evaluate the effect on liver fibrosis (by Fibroscan®) and serum TGF
- Evolution of hepatocellular function estimated by the scores of Child-Pugh and MELD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis of any etiology diagnosed by previous biopsy or clinical, laboratory and sonographic criteria
- •Hospital admission at least 3 days, because of decompensated liver disease (ascites, encephalopathy, controlled gastrointestinal bleeding, spontaneous bacterial peritonitis)
- •signed written consent
- •Women of child-bearing age use effective contraception
排除标准
- •Age <18 and >80 years
- •contraindication to treatment with heparins
- •uncontrolled hemorrhage
- •Any comorbidity involving a therapeutic limitation and / or a life expectancy <6 months
- •concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole, sulfinpyrazone, dextran 40, or other anticoagulants
- •and continued concomitant NSAIDs, salicylates, corticosteroids
- •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)
- •Refusal to participate in the study, or to sing informed consent
- •Pregnancy or lactation
- •HIV infection
- •platelet count <20,000 platelets / dl
- •renal clearance below 30ml / min
- •portal vein thrombosis or peripheral thrombosis diagnosed at admission
- •presence of procoagulant factor previously known
研究组 & 干预措施
Bemiparin
Experimental
Bemiparin 3.500 U, once a day during hospitalization
干预措施: Bemiparin (Drug)
结局指标
主要结局
Number of patients with bleeding and liver toxicity under Bemiparin treatment (HIBOR®) for the prevention of DVT / portal vein thrombosis.
时间窗: 90 days
The bleeding will be classificated in two grades ( mild/ severe) and hepatoxicty were asses according to NCI CTCAE Version 3.0
次要结局
- Number of thrombotic events in cirrhotic hospitalized patients(90 days)
研究者
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