Utilization of Donor Whole Blood for Blood Transfusion in Deceased Donor Liver Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Use of allogenic banked blood products
研究概览
简要总结
We will study 40 matched patients. 20 patients will receive leukoreduced whole blood from the solid organ donor. These 20 patients will be compared to 20 historical matched controls with regards to allogenic blood product usage and other physiologic markers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Recipients 18 years or older.
- •Deceased donor whole graft liver transplant recipients undergoing liver transplant starting 07/01/2020 and onwards at VUMC.
- •ABO-matched recipient and donor.
- •Donor Hb level >/= 8 g/dL
- •Recipients with negative ABO antibody screen
排除标准
- •- Pediatric recipient.
- •HBS Antigen+ donors
- •HCV NAT+ donors
- •Donors of A2 blood type
- •Donors on oral anticoagulants (except for aspirin) over the past 3 days before organ procurement
研究组 & 干预措施
Donor Blood
Between 2-4 units of donor leukoreduced whole blood (each unit will contain up to 350mL) transfused as needed in Liver transplantation participants
干预措施: Donor Blood (Biological)
Banked Blood
Standard of Care - Up to 350mL Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets) transfused as needed in Liver transplantation participants
干预措施: Banked Blood (Biological)
结局指标
主要结局
Use of allogenic banked blood products
时间窗: perioperative up to 72 hours post operative
Measured by the number of allogenic banked blood products used
Economic cost
时间窗: perioperative up to 72 hours post operative
Total cost of perioperative transfusions
次要结局
- Number of Serious Adverse Events (SAEs)(Baseline to discharge (approximately 4-5 days))