Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-26 @ 11:24 PM
Study NCT ID:
NCT05096351
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACIMALLOGV
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: