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

Last updated: May 3, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Organ Transplant

Treatment

Blood test

Clinical Study ID

NCT05096351
LOCAL/2021/EF-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anarterial bypass in the lower limb or an arteriovenous bypass in the upper limb withinthe framework of the creation of arteriovenous fistulas in dialysis patients, in theabsence of available autologous venous material.

Exclusion

Exclusion Criteria:

  • The subject is participating in a category 1 interventional study, or is in a periodof 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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Blood test
Phase:
Study Start date:
June 08, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHU de Nîmes

    Nimes,
    France

    Active - Recruiting

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