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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Oct 15, 2021

Keywords

ClinConnect Summary

This clinical trial, called Bioprotec, is studying how the immune system of patients reacts after receiving a special type of blood vessel graft (called a saphenous venous allograft) that has been stored at cold temperatures. The researchers at the University Hospital of Nîmes will take blood tests from participants before and after the graft is placed to see if there are any immune responses that could affect future organ transplants. If they find that some patients have a strong immune reaction, they might change how they select patients for these grafts to help prevent problems with future organ transplants.

To be eligible for this study, participants need to be covered by a health insurance plan and are scheduled to receive a venous graft for specific types of surgeries, like improving blood flow in the legs or for dialysis access, when their own veins aren't available. The trial is currently recruiting participants aged 65 to 74, and it’s important to note that individuals who have had previous grafts or organ transplants, or who are pregnant or breastfeeding, cannot take part. Participants can expect to have their blood tested before and after their surgery, helping researchers understand how these grafts impact their immune systems.

Gender

ALL

Eligibility criteria

• 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