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

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.

Study Overview

• Status: Recruiting
• Conditions: Allograft; Cold Temperature; Saphenous Vein
• Intervention / Treatment: Other: Blood test

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Elsa Faure; Phone Number: 04.66.68.39.30; Email: elsa.faure@chu-nimes.fr

Study Locations

• France
  • Nimes, France
    • Recruiting
    • CHU de Nimes
    • Principal Investigator: Elsa Faure
    • Sub-Investigator: Eric Picard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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
• Presence of donor-specific antibodies in HLA-immunized patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with venous allograft	Other: Blood test; Collection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of donor specific antibodies after venous allograft	Presence/absence of donner anti-HLA antibodies in patient blood, detected using Luminex assay	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allograft anomalies linked to allograft rejection	Inflammation, thrombosis, aneurysms progression	1 month
Allograft anomalies linked to allograft rejection	Inflammation, thrombosis, aneurysms progression	6 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Elsa Faure, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LOCAL/2021/EF-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No