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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver transplant recipients receiving blood donors' transfusion | Experimental | Liver transplant recipients in which donor blood was collected and intraoperatively transfused to recipients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Blood Cell concentrates from organ donor | Biological | Intervention is a 3-step procedure consisting of 1) recovering blood from the donor during organ procurement; 2) processing donor blood to RBC units; 3) transfusing donor blood to recipients, if necessary during surgery.
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant. | Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant. | within surgical LT procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Teofili | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A.Gemelli IRCCS | Rome | 00168 | Italy |
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| within surgical LT procedure |
| Rate of graft failure in the prospective sample, as compared to controls. | Rate of graft failure in the prospective sample, as compared to controls. | 3 months |