Blood Salvage From Liver Donors: a Feasibility Pilot Study

Liver Transplantation Clinical Trial

— BLEED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835882
• Other study ID #: ID5429
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Luciana Teofili
• Phone: +39 06 30154180
• Email: luciana.teofili[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythrocyte Transfusion
• Liver Transplantation

Intervention

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).

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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