Blood Salvage From Liver Donors: a Feasibility Pilot Study. (BLEED Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant.
研究概览
简要总结
Blood recovery is a common procedure that limits patient exposure to allogeneic blood products. Blood recovery is usually performed during different types of surgery, including cardiac and vascular surgery, or liver transplantation. Basically, the process utilizes blood cell savers and cell separators and is finalized to auto-transfusion. In our hospital, the blood recovery is carried out with the CATSmart continuous-flow device (Fresenius Kabi AG, Bad Homburg, Germany) that warrants the removal of > 95% of heparin, potassium, free hemoglobin, and non-emulsifiable lipids. In liver transplantation (LT), before removing the organ from the donor, the blood is usually flushed out of the liver. Nonetheless, in some circumstances, donor blood cells may be transferred to recipients together with the solid organ during graft implantation. This is a feasibility study exploring RBC (red blood cell) concentrates obtained from the blood organ donor to support transfusion requirements in liver recipients. Donor RBC units are produced according to the quality standards recommended by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe, with equivalent content of Hb and residual leukocytes as standard RBC products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •All adult patients (≥ 18 years) receiving a liver transplant from deceased donors at Fondazione Policlinico A. Gemelli IRCCS are eligible for the study.
- •Liver procurement at Fondazione Policlinico A. Gemelli IRCCS.
- •Identical ABO group in donor and recipient.
- •Signed written informed consent to study participation.
排除标准
- •Age <18 y.o.
- •D-negative recipient with D-positive donor.
- •Cytomegalovirus-negative recipient and cytomegalovirus -positive donor.
- •Refusal to sign written informed consent to study participation.
研究组 & 干预措施
Liver transplant recipients receiving blood donors' transfusion
Liver transplant recipients in which donor blood was collected and intraoperatively transfused to recipients.
干预措施: Red Blood Cell concentrates from organ donor (Biological)
结局指标
主要结局
Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant.
时间窗: within surgical LT procedure
Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant.
次要结局
- Blood product need in enrolled patients, in terms of rate of LT patients receiving no additional blood product in comparison with a control-matched series of LT patients accrued in previous observational protocol.(within surgical LT procedure)
- Rate of graft failure in the prospective sample, as compared to controls.(3 months)