Blood Salvage From Liver Donors: a Feasibility Pilot Study (BLEED)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Liver Transplantation; Erythrocyte Transfusion

Treatments: Biological: Red Blood Cell concentrates from organ donor

Study type: Interventional

Funder types: Other

Identifiers

NCT05835882

ID5429

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Liver transplant recipients receiving blood donors' transfusion

Experimental group

Description:

Liver transplant recipients in which donor blood was collected and intraoperatively transfused to recipients.

Treatment:

Biological: Red Blood Cell concentrates from organ donor