Liver Transplantation Clinical Trial
— BLEEDOfficial title:
Blood Salvage From Liver Donors: a Feasibility Pilot Study. (BLEED Study)
NCT number | NCT05835882 |
Other study ID # | ID5429 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2023 |
Est. completion date | June 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A.Gemelli IRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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 |
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