Examining immune reactions after cold-stored venous allograft placement
Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
Centre Hospitalier Universitaire de Nīmes · NCT05096351
This study is testing how patients' immune systems react after receiving cold-stored vein grafts to see if it affects their chances for future kidney transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes (other) |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT05096351 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the immune response in patients receiving cold-stored saphenous venous allografts at the University Hospital of Nîmes. Blood tests will be conducted before and after the allograft placement to assess the occurrence of immune reactions related to the allograft. The findings may lead to changes in patient management, particularly regarding eligibility for future renal transplants. The study focuses on understanding how the BIOPROTEC method affects immune responses in these patients.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for venous allograft procedures at the CHU of Nîmes who lack available autologous venous material.
Not a fit: Patients who have previously received a venous allograft or organ transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk of immune reactions, thereby improving outcomes for future organ transplants.
How similar studies have performed: While similar studies on immune responses to allografts exist, this specific approach using cold-stored venous allografts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient must be a member or beneficiary of a health insurance plan * Patients receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material. Exclusion Criteria: * The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * The subject has already been included in the study * The subject refuses to participate * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Patient previously having received a venous allograft or organ transplant * Pregnant, parturient or breastfeeding patients
Where this trial is running
Nîmes
- CHU de Nîmes — Nîmes, France (RECRUITING)
Study contacts
- Principal investigator: Elsa Faure — CHU Nimes
- Study coordinator: Elsa Faure
- Email: elsa.faure@chu-nimes.fr
- Phone: 04.66.68.39.30
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.
Conditions: Allograft, Cold Temperature, Saphenous Vein