Intraoperative Phlebotomy in Living Donor Liver Transplant- Means to Minimize Blood Transfusion: A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- • To compare intraoperative red cell transfusion requirements (measured in units) between the groups.
研究概览
简要总结
Aim of study: To prospectively study the effects of intraoperative phlebotomy on blood transfusion requirements during living donor liver transplantation in a randomised controlled trial.
Background/Origin of the proposal: Intraoperative blood loss during living donor liver transplantation (LDLT) contributes significantly to morbidity, transfusion-related complications, and graft dysfunction. One strategy used to reduce venous bleeding is controlled phlebotomy, which aims to reduce central venous pressure particularly during the pre-anhepatic phase.
Rationale of the study supported by cited literature for the hypothesis and primary objective – Portal hypertension contributes significantly to the blood loss during liver transplant surgery. Controlled phlebotomy helps to reduce portal hypertension in the dissection phase and thereby helps in reducing blood loss.
Primary objective of our study is to assess intra-operative red cell requirement in patients undergoing controlled phlebotomy.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged between 18-65years planned to undergo living donor liver transplant.
排除标准
- ••Patients who refuse to consent to participate in the study.
- ••Patients aged less than 18years of age.
- ••Patients of acute liver failure •Patients planned for re-transplantation.
- ••Patients planned for combined procedure (SLKT, LT+CABG) •Patients with preoperative haemoglobin less than 7.0 gm/dl •Patients with EF less than 50% •Patients with chronic kidney disease, eGFR less than 30ml/min/1.73m2 MDRD, H/O renal replacement therapy within last two weeks.
结局指标
主要结局
• To compare intraoperative red cell transfusion requirements (measured in units) between the groups.
时间窗: • intraoperative period
次要结局
- Secondary Outcomes:(• Intraoperative fluid requirement [Crystalloids (ml); Colloids (ml) and 25% Albumin(ml)])
研究者
Dr Prachi Gokula
Medanta, The Medicity