Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- POD 7 Platelet Counts
研究概览
简要总结
This project is a pilot randomized controlled trial aimed at investigating the potential of Carica Papaya Leaf Extract, available in a marketed pill formulation, in increasing platelet counts in live donor liver transplant recipients. Carica Papaya leaf extract has shown positive results in increasing platelet counts in various medical conditions such as Dengue, Immune thrombocytopenic purpura and chemotherapy induced thrombocytopenia. Thrombocytopenia i.e. low platelet counts are a common occurrence in patients with chronic liver disease undergoing live donor liver transplant. It has been observed in previous studies that live donor liver transplant recipients who have persistent thrombocytopenia have significantly worse outcomes as compared to patients who have higher platelet counts. Positive results in this study lead to further studies in assessing the impact of platelet augmentation in live donor liver transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.
排除标准
- •Patients who do not consent
- •ALF & ACLF
- •Pediatric transplant recipients
- •Allergic to papaya
- •Preoperative platelet counts >75,000/ μL
- •Recent history of DVT
研究组 & 干预措施
Carica Papaya Arm
1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.
干预措施: Carica Papaya Leaf Extract (Drug)
Placebo Arm
Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.
干预措施: Placebo (Other)
结局指标
主要结局
POD 7 Platelet Counts
时间窗: 7th post-operative day
次要结局
- Pre-operative platelet counts(1 day prior to surgery)
- Intra-operative blood loss and transfusion requirements(Day 0)
- Incidence of prolonged post-operative drainage(First 14 days following live donor liver transplant)
- Incidence of Early allograft dysfunction(First 7 days following live donor liver transplant)