Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05096351
Acronym
REACIMALLOGV
Enrollment
50
Registered
2021-10-27
Start date
2022-06-08
Completion date
2025-12-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft, Cold Temperature, Saphenous Vein

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.

Interventions

OTHERBlood test

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of donor specific antibodies after venous allograft1 monthPresence/absence of donner anti-HLA antibodies in patient blood, detected using Luminex assay

Secondary

MeasureTime frameDescription
Allograft anomalies linked to allograft rejection1 monthInflammation, thrombosis, aneurysms progression

Countries

France

Contacts

Primary ContactElsa Faure
elsa.faure@chu-nimes.fr04.66.68.39.30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026