Blood Salvage From Liver Donors: a Feasibility Pilot Study

Not Applicable

Recruiting

• Conditions: Liver Transplantation; Erythrocyte Transfusion
• Interventions: Biological: Red Blood Cell concentrates from organ donor

• Registration Number: NCT05835882
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-28
• Study Start: 2023-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver transplant recipients receiving blood donors' transfusion	Red Blood Cell concentrates from organ donor	Liver transplant recipients in which donor blood was collected and intraoperatively transfused to recipients.

Primary Outcome Measures

Name	Time	Method
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	Number and percentage of LT recipients successfully transplanted with internal donors, who received donor RBC concentrates for the intraoperative transfusion support during liver transplant.

Secondary Outcome Measures

Name	Time	Method
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	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.
Rate of graft failure in the prospective sample, as compared to controls.	3 months	Rate of graft failure in the prospective sample, as compared to controls.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS; 🇮🇹 Rome, Italy