NCT05096351

Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients. The aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the BIOPROTEC method. In case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.

Conditions

• Allograft
• Cold Temperature
• Saphenous Vein

Interventions

Type	Name	Description
OTHER	Blood test	Collection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies

Timeline

• Start date: 2022-06-08
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-10-27
• Last updated: 2024-05-06

Locations

1 site across 1 country: France