VCA (Hand Transplantation): Functional and Quality of Life Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Allograft survival
研究概览
简要总结
There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. The Transplant Center would like to track the patient experience from pre-operative care through surgery and post-operative care.
Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; Surgical information ; Post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.
详细描述
Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. The technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields.
Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.
Specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study.
排除标准
- •Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.
结局指标
主要结局
Allograft survival
时间窗: Transplant through end of study (5 years)
Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5
次要结局
- Quality of life(Transplant through end of study (5 years))
- Immunosuppression requirements(Transplant through end of study (5 years))
- Allograft rejection(Transplant through end of study (5 years))
- Allograft Function(Transplant through end of study (5 years))
研究者
Kagan Ozer
Associate Professor
University of Michigan