Prospective PeriOperative study Evaluating Routine Coagulation versus Thromboelastography for Liver resections (PORTAL 2 Trial )
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary aim of our study is to study the serial changes of conventional coagulational tests and thromboelastography in cirrhotic patients undergoing major liver resection during perioperative period
研究概览
简要总结
The purpose of our study is to study the serial changes of conventional coagulation tests and thromboelastography (both are tests for assessing the clotting status of the patient) during post operative period in patients undergoing major liver resection (more than 3 segment).
Unlike traditional coagulation assays, which measure components of blood and portions of the coagulation pathway separately, TEG uses whole blood to measure functional coagulation. This allows for active involvement of the red blood cell, white blood cell, platelet and plasma components of coagulation.
Bleeding and vascular thrombosis are major life threatening complications following liver surgery. Following major hepatectomty, there will be altered clotting status, do even when the routine tests are high and TEG is normal, blood transfusions can be avoided, and complications from blood transfusions can be avoided.
This study will be initiated after approval from the institutional ethics committee and registration with CTRI. 20 patients with cirrhosis as determined by Fibroscan posted for liver resection other than those meeting exclusion criteria will be included in this prospective interventional study. Consent for the participation in the study will be taken from all eligible patients. Blood samples will be taken from the patient after getting admitted in hospital. The patient will be taken blood samples at five point of time 1. Preincision (after anaesthetized and before surgery), 2. During intraop (during surgery time as per ot anaesthetist), 3. Immediately after surgery, 4. At 48 hrs and 5. On day 5. Blood samples will be taken for CBC (normal blood test for hemoglobin, and cell counts), routine coagulation tests and TEG.
In this study patient’s medical records will be assessed for the demographic details (age, sex, and weight etc.), clinical data (primary diagnosis and details of surgery) and the blood test reports will be recorded at various intervals as per study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •20 patients with cirrhosis as determined by Fibroscan (Fibrosis score 4) posted for liver resection will be included in the study.
排除标准
- •On therapeutic doses of thromboprophylaxis , Abnormal coagulation or platelets , Any known coagulation disorders , Refusal of consent , Fibrosis score ≤ F3.
结局指标
主要结局
The primary aim of our study is to study the serial changes of conventional coagulational tests and thromboelastography in cirrhotic patients undergoing major liver resection during perioperative period
时间窗: 1.Preincision | 2.Intraoperative (based at discretion of OT anaesthetists) | 3.Postoperative | 4.48 hrs post surgery | 5.5th post surgery
次要结局
- 1. To record the incidence of prevention of transfusion of blood products(2. Incidence of complications)