Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Presence of donor specific antibodies after venous allograft
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Presence of donor specific antibodies after venous allograft
时间窗: 1 month
Presence/absence of donner anti-HLA antibodies in patient blood, detected using Luminex assay
次要结局
- Allograft anomalies linked to allograft rejection(6 month)