Thromboelastography guided blood product transfusion in cirrhosis patients with acute variceal bleeding: a Randomized Controlled Trial

Department of Gastroenterology AIIMS New Delhi1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2017年1月3日最近更新: 2018年5月20日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 100
试验地点: 1
主要终点: Reduction in the requirement of blood products between the two groups.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Our aims of the study is to assess the role of TEG in guiding transfusion of blood products in patients with variceal UGI bleed. Presently patients with UGI bleed are transfused platelets and fresh frozen plasma prophylactically. The results might be will be useful in changing the management protocols for UGI bleed. We expect that TEG based therapy will reduce the need for prophylactic transfusion of blood products.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•1.Cirrhosis with acute variceal bleeding 2.Age between 18-65 years 3.Willing to participate in the study.

排除标准

•1.Variceal bleeding secondary to causes other than cirrhosis.
•eg, extrahepatic venous obstruction, hepatic venous outflow track obstruction 2.Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (haemophilia) apart from cirrhosis.
•3.History of intake of platelets inhibitors (eg, aspirin, clopidogrel) and drugs affecting coagulation cascade (eg, vitamin K anatagonists) within past 7 days 4.Pregnant women and those on oral contraceptives 5.Patients with chronic renal failure 6.History of underlying hypercoagulable/ hypocoagulable states eg.
•paroxysmal nocturnal hemoglobunuria (PNH), polycythemia vera etc 7.Patients receiving blood products (fresh frozen plasma and platelet prior to thromboelastography) 8.Patients with shock 9.Sepsis 10.Acute on chronic liver failure 11.Hepatorenal syndrome 12.Hepatic encephalopathy 13.Contraindication to endoscopy 14.Not willing to provide consent.

结局指标

主要结局

Reduction in the requirement of blood products between the two groups.

时间窗: 24 hours, 120 hours

次要结局

1.Control of variceal bleeding at 24 hours and 5 days.(2.Rebleeding and mortality at 6 weeks.)

研究者

发起方

Department of Gastroenterology AIIMS New Delhi

申办方类型

Research institution and hospital

研究点 (1)

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