Actively Recruiting

Age: 18Years +
All Genders
NCT05096351

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-05-06

50

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 as part of dialysis fistula creation
  • No available autologous venous material for the bypass
Not Eligible

You will not qualify if you...

  • Participating in a category 1 interventional study or within exclusion period from a previous study
  • Previously included in this study
  • Refusal to participate
  • Unable to provide informed information
  • Under legal guardianship or safeguard of justice
  • Previously received a venous allograft or organ transplant
  • Pregnant, parturient, or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Nîmes

Nîmes, France

Actively Recruiting

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Research Team

E

Elsa Faure

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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