Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion (CAssIOPé)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 53
- 主要终点
- Detection of DSA at 6 months
研究概览
简要总结
This is a prospective, monocentric, observational cohort study whose main objective is to describe the number and rate of patients who developed DSAs (Donor Specific Antibody) at 6 months post-surgery with implantation of a cryopreserved lung homograft.
详细描述
Lung homograft is used in a large number of complex malformations. It is accepted that homografts may induce immune reactions in the recipient, but no immunological studies have been carried out to characterize the recipient's immune reactions to the homograft and their potential impact on valve function. In this project, the authors propose to study the immunizing character of cryopreserved lung homografts by identifying the appearance of antibodies directed against the HLA, DSA (Donor Specific Antibodies) molecules of the graft (lung homograft) at 1 month and 6 months after its surgical implantation.The primary objective will be analyzed by describing the rate of patients who developed DSA at 6 months post-surgery with implantation of a cryopreserved lung homograft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for control patients:
- •Patient receiving a cryopreserved pulmonary valve homograft
- •Patient aged 14 or over
- •Signature of consent by adult patients/parents/guardians and assent by children
- •Inclusion Criteriafor patients with lung homograft :
- •Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft
排除标准
- •for both group
- •Emergency surgery patient
- •Pregnant women or childbirth within the last 6 months
- •Transfusion during the surgery or within the last 6 months
- •Patient with DSAs detected before the surgery
- •Patient with anti-HLA antibodies (non-DSAs) detected before the surgery
研究组 & 干预措施
Control patients
Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft
干预措施: Blood collection T0 (Procedure)
Control patients
Patients with an indication for cardiac surgery with extracorporeal circulation but without homograft
干预措施: Blood collection 6 months (Procedure)
Lung homograft patients
patients requiring lung homograft implantation
干预措施: Blood collection T0 (Procedure)
Lung homograft patients
patients requiring lung homograft implantation
干预措施: Blood collection 6 months (Procedure)
结局指标
主要结局
Detection of DSA at 6 months
时间窗: 6 months
Luminex® detection of DSA at 6 months after lung homograft implantation
次要结局
- antibody anti-HDLA (non DSA) detection(6 months)
- Early degeneration of the homograft(6 months)
- DSA Quantification(6 months)