ClinicalTrials.gg
Status unknownNCT05096351REACIMALLOGVUpdated May 6, 2024

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

An observational study in Allograft, Cold Temperature and Saphenous Vein, sponsored by Centre Hospitalier Universitaire de Nīmes. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Allograft
  • Cold Temperature
  • Saphenous Vein
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In context

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 594 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with venous allograft

    Other: Blood test

Interventions

  • OtherBlood test

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

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What researchers measure

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

    Time frame: 1 month

Secondary outcomes

  1. Allograft anomalies linked to allograft rejection

    Inflammation, thrombosis, aneurysms progression

    Time frame: 1 month

  2. Allograft anomalies linked to allograft rejection

    Inflammation, thrombosis, aneurysms progression

    Time frame: 6 month

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Study locations

1 of 1 sites recruiting
  • CHU de Nîmes
    Nîmes, France
    • Anissa Megzari · Contact · drc@chu-nimes.fr · 04.66.68.42.36
    • Elsa Faure · Principal investigator
    • Eric Picard · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05096351
Responsible party
Sponsor
First posted
Oct 27, 2021
Start date
Jun 8, 2022
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 6, 2024

Study contacts

Elsa Faure
Contact
elsa.faure@chu-nimes.fr
04.66.68.39.30
Elsa Faure
principal investigator · CHU Nimes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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