Thromboelastography versus Rotational Thromboelastometry Guided Blood Transfusion in Living Donor Liver Transplantation - A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total PRBCs transfused between two groups.
研究概览
简要总结
On the day of surgery, patient will be transferred to operation theatre. All ASA standard monitors will be attached.
**Institute protocol for conduct of anesthesia will be followed.****Normothermia will be maintained.****Patients will be randomized into TEG group and ROTEM group. Block randomization will be done.**Sample size being 80, 8 blocks will be used and in each block, 10 patients will be taken and among those 10 patients, 5 patients will be allocated TEG group and 5 patients will be allocated ROTEM group
Blood samples will be drawn from an existing arterial catheter. Either TEG or ROTEM will be performed as per randomised chart. All tests will be performed by designated group of anaesthesia technicianse
TEG GROUP
In patients belonging the TEG group, blood will be collected in 3.5-mL tubes containing 3.2% citrate for assay with the TEG 5000 Haemostatic Analyser (Haemonetics, Braintree, MA).
The following TEG measurements will be recorded: R time (minutes), angle (alpha, degrees), K (kinetics), maximum amplitude (MA, mm), FF TEG, lysis 30 min after MA (LY30, %), coagulation index.
On the day of surgery, patient will be transferred to operation theatre. All ASA standard monitors will be attached.
Institute protocol for conduct of anesthesia will be followed.
Normothermia will be maintained.
Baseline TEG and ROTEM will be performed**.**
Patients will be randomized into TEG group and ROTEM group. Block randomization will be done.
Sample size being 80, 8 blocks will be used and in each block, 10 patients will be taken and among those 10 patients, 5 patients will be allocated TEG group and 5 patients will be allocated ROTEM group
Blood samples will be drawn from an existing arterial catheter. Either TEG or ROTEM will be performed as per randomised chart. All tests will be performed by designated group of anaesthesia technicianse
TEG GROUP
In patients belonging the TEG group, blood will be collected in 3.5-mL tubes containing 3.2% citrate for assay with the TEG 5000 Haemostatic Analyser (Haemonetics, Braintree, MA).
The following TEG measurements will be recorded: R time (minutes), angle (alpha, degrees), K (kinetics), maximum amplitude (MA, mm), FF TEG, lysis 30 min after MA (LY30, %), coagulation index.
ROTEM GROUP
For patients undergoing ROTEM (ROTEM assay, Pentapharm GmbH, Germany), blood will be collected in 3.2% citrate tubes EXTEM, FIBTEM will be performed
Thromboelastometric parameters to be analysed: (1) clotting time (CT), (2) clot formation time (CFT), (3) clot firmness after 10 minutes (A10 min), and maximum clot firmness (MCF), FIBTEM MCF,and maximum lysis at 30 minutes .
TEG and ROTEM guided correction will be done as per algorithm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients undergoing living donor liver transplant at our institute.
排除标准
- •Acute liver failure patients, Acute on chronic liver failure patients 2) Pediatric patients 3)Retransplantation in a patient previously randomized in this trial 4) Without informed consent 5) Patients with known coagulation factor deficiencies.
结局指标
主要结局
Total PRBCs transfused between two groups.
时间窗: Baseline, dissection phase, anhepatic phase, post reperfusion and postoperative day 1 ,2 and 3
次要结局
- 1 To compare the amount of FFP,Cryoprecipitate & platelets transfused between both groups(2.To compare the changes in coagulation during different stages of liver transplant between the two groups)
研究者
Dr Rachana C Nair
Institute Of Liver and Biliary Sciences (ILBS)