Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Diagnosis of AMR
研究概览
简要总结
The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.
Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient older than 18 years
- •Transplanted pulmonary or cardiopulmonary patient
- •And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold > 1000 of MFI in the 30 days preceding the inclusion visit
- •Affiliation to the French social security
- •Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent
排除标准
- •Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
- •Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
- •Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)
- •Plasma exchanges (less than 3 months before inclusion)
- •Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)
- •Impossibility of giving the subject informed information
- •Subject under the protection of justice Subject under guardianship or curatorship
- •Pregnancy
- •Breastfeeding
结局指标
主要结局
Diagnosis of AMR
时间窗: 2 years
Sensitivity and specificity of the presence of gDSA for the diagnosis of AMR in lung transplant recipients with circulating DSA, as established by an expert pathologist panel and in accordance with recent international recommendations
次要结局
- Comparaison in gDSA+ vs gDSAs- patients(2 years)