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

Allograft Clinical Trial

— REACIMALLOGV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05096351
• Other study ID #: LOCAL/2021/EF-01
• Status: Recruiting
• Start date: June 8, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Elsa Faure
• Phone: 04.66.68.39.30
• Email: elsa.faure[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allograft
• Saphenous Vein

Intervention

Other:
• Blood test
Collection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies

Locations

Country	Name	City	State
France	CHU de Nîmes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Allograft anomalies linked to allograft rejection	Inflammation, thrombosis, aneurysms progression	1 month
Secondary	Allograft anomalies linked to allograft rejection	Inflammation, thrombosis, aneurysms progression	6 month