A Prospective, Randomized Clinical Trial Comparing Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy: Rotational Thromboelastography (ROTEM) Versus Conventional Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Intra-operative Blood Loss
研究概览
简要总结
A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).
详细描述
Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 and older, admitted to the hospital
- •Patients who have clinically documented cirrhosis
- •Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000)
- •Patients undergoing an endoscopic procedure or neurosurgical procedure
排除标准
- •Patients must not be pregnant
- •Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)
- •Patients must not have an active infection (per PI discretion)
- •Patients must not have any known hemostatic disorder
结局指标
主要结局
Intra-operative Blood Loss
时间窗: Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).
Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.
次要结局
- Number of Participants With Bleeding Events(Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).)
研究者
James Hanje
Associate Professor
Ohio State University