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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Erythrocyte Transfusion
• Intervention / Treatment: Biological: Red Blood Cell concentrates from organ donor

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario A.Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Liver transplant recipients receiving blood donors' transfusion; Liver transplant recipients in which donor blood was collected and intraoperatively transfused to recipients.

Biological: Red Blood Cell concentrates from organ donor; 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.; Donor blood recovery. A: Donor evaluation. During the donor workup, the donor coordinator team gathers additional information from the donor relatives. If no contraindication to blood collection exists, the donor-recipient ABO-crossmatch is performed, and if negative the donor is considered eligible. B: Donor blood collection. It is carried out by a trained investigator, through the continuous autotransfusion system CATSmart (Fresenius Kabi) in the surgery room.; Donor blood processing, carried out using the continuous flow CATSmart device. About 4 RBC units are collected.; Donor RBC unit transfusion to recipients according to procedures usually adopted at our hospital (final hb level 8-9 g/dL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Luciana Teofili, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ID5429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No