Blood Salvage From Liver Donors: a Feasibility Pilot Study

NCT05835882 | Completed DMC

• 1 other identifier: ID5429
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Erythrocyte Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Liver transplant recipients receiving blood donors' transfusion

EXPERIMENTAL

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

Biological: Red Blood Cell concentrates from organ donor

Interventions

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. 1. 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. 2. Donor blood processing, carried out using the continuous flow CATSmart device. About 4 RBC units are collected. 3. Donor RBC unit transfusion to recipients according to procedures usually adopted at our hospital (final hb level 8-9 g/dL).

Liver transplant recipients receiving blood donors' transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, 00168, Italy

Location

Study Officials

• Luciana Teofili

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: April 28, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-06

Locations

IT (1)