Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding: A Randomized Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cumulative volume of FFP transfused at Day 5.
研究概览
简要总结
AIM:- To compare Rotational thrombo- elastometry vs Thrombo- elastography as a guide for blood component transfusion in patients of Cirrhosis with nonvariceal bleeding.
Methodology:- After fulfilling all inclusion and exclusion criteria, patients were randomized to either the TEG or ROTEM group in a 1:1 proportion. Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.In ROTEM group if CT EXTEM >80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM <35 and MCF FIBTEM <8 CRYO or Fibrinogen concentrate, if MCF EXTEM<35 and MCF FIBTEM >8 Platelet, CL LY>50 Trenaxemic acid
Study population: patients with Cirrhosis of liver with nonvariceal bleeding
Study design: Randomized controlled trial
Study period: 1 years after ethical clearance
Sample size: Assuming that total volume of FFP used in TEG 760 ± 370 and further in ROTEM volume used 510±275 with α 5% power 90, we need to enrol 72 cases. Further assuming 10% inadequacy We had decided to enroll a total of 80 patients, 40 in each group.The allocation will be done randomly by block randomization method.
Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.
STATISTICAL ANALYSIS:
The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous data will be compiled using t-test. Besides this the univariate and multivariate survival analysis will be carried out using Cox regression method. Kaplan-Meier technique will be applied for further analysis. P-value<0.05 will be considered as significant.
Adverse effects:Transfusion related complication
Stopping rule: If patient decided to withdraw from study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Cirrhosis of any etiology
- •Age between 18 and 80 years;
- •Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing
- •bleed form a nonvariceal source); and
- •Significant coagulopathy assessed by CCTs (INR > 1.8 and/or PLTs < 50 × 109/L).
排除标准
- •Variceal bleed
- •Post Variceal ligation ulcer bleed
- •Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel;
- •Anti-PLT or anticoagulant therapy at the time of enrollment or that had been discontinued less than 7 days before evaluation for the study;
- •Pregnancy 6.
结局指标
主要结局
Cumulative volume of FFP transfused at Day 5.
时间窗: Day 5.
次要结局
- Cumulative volume of Cryoprecipitate, Platelet and Trenaxemic acid(Transfusion related reactions)
- Duration of intensive care unit (ICU) and hospital stay; and(Survival at 6 weeks)
研究者
Dr Saurav Paul
Institute of Liver and Biliary Sciences