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

NCT05096351 | Recruiting

• 1 other identifier: LOCAL/2021/EF-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Allograft anomalies linked to allograft rejection

  1 month

• Allograft anomalies linked to allograft rejection

  6 month

Study Arms (1)

Patients with venous allograft

Other: Blood test

Interventions

Blood test OTHER

Collection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies

Patients with venous allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, cell pellets, venous tissue

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Elsa Faure

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsa Faure

CONTACT

04.66.68.39.30; elsa.faure@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: June 8, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

FR (1)