Using blood from liver donors to reduce transfusion needs in transplant patients
Blood Salvage From Liver Donors: a Feasibility Pilot Study. (BLEED Study)
This study is testing if using red blood cells from liver donors can help liver transplant patients need fewer blood transfusions and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT05835882 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility of recovering red blood cell concentrates from deceased liver donors to minimize the need for allogeneic blood transfusions in liver transplant recipients. The process involves utilizing a continuous-flow device to ensure the safe collection and preparation of donor blood cells. By transferring these cells to the transplant recipients, the study aims to enhance patient outcomes and reduce exposure to external blood products during liver transplantation. The study is conducted at Fondazione Policlinico A. Gemelli IRCCS in Rome.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older receiving a liver transplant from deceased donors with an identical ABO blood group.
Not a fit: Patients under 18 years old or those with incompatible blood types will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the reliance on donor blood products for liver transplant patients, improving safety and outcomes.
How similar studies have performed: While the concept of blood salvage is established in other surgical fields, this specific application in liver transplantation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rome
- Fondazione Policlinico Universitario A.Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Luciana Teofili — Fondazione Policlinico Universitario A. Gemelli, IRCCS
- Study coordinator: Luciana Teofili
- Email: luciana.teofili@unicatt.it
- Phone: +39 06 30154180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.