Bilateral Allotransplantation of Upper Limbs
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities
研究概览
简要总结
The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •State of brain death
- •Compatibility with recipient about sex, size, age and color
- •Blood compatibility; integrity of upper limbs
- •Double amputation of hands or forearms with traumatic origin
- •Personal motivation
- •Good health condition
- •Delay from 2 months to 34 years between amputation and transplantation
排除标准
- •Uncompatibility with sample
- •Lesion on upper limbs
- •Neoplasia
- •Hepatitis B or C
- •Positive CMV serology
- •Uncompatibility with immunosuppressant treatment
- •Psychosis
- •Carcinosis
- •Cardiovascular diseases
- •Addiction to alcohol or smoking
- •Pregnancy
结局指标
主要结局
Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities
时间窗: 6 years
次要结局
- Aesthetic and psychologic(6 years)