Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness
试验速览
- 阶段
- 不适用
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Number of successful organ transplantation among those sampled.
研究概览
简要总结
In the complex process of organ transplant, two of the major steps are:
- evaluation of the organs of potential donors in health institutions:
- proposing grafts to the transplant teams, according to rules defined at the national level.
In the absence of the possibility of transmitting the images between the deceased donor sites and the transplant teams, the visualization of these examinations does not take part in the decision-making of the transplant team. This leads in the displacement of the transplant team in order to verify the grafts after acceptance of the graft proposal.
The "Cristal Image" project is a visualisation project for the transplant teams, in real time, at the time of the proposal of the graft so that they can give an opinion (acceptance, refusal) in less than 20 minutes (legal delay for a vital organ) after analyzing the medical records provided and the imaging data (scanner, ultrasound (s), coronary angiography, etc.).
The hypothesis of the project is that the implementation of a secure image transmission (complete anonymisation of the data of the donor) before the acceptance by the team, will allow an optimization of the use of the qualified organs by reducing risks, unnecessary displacement of transplant surgical teams, and securing the allocation of organs to recipient patients.
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
- •French Donors who died in brain death, at least one organ of which was proposed for transplantation (kidneys, liver, heart, lung); Recipients transplanted during the same periods.
排除标准
- •Donors who died after cardiac arrest
- •Donors taken care in a foreign country or outside the Metropolitan France
结局指标
主要结局
Number of successful organ transplantation among those sampled.
时间窗: 3 months after transplantation for kidney, 1 year after transplantation for the other organs
次要结局
- Number of assigned organs but not sampled(Immediately after the decision of the transplant team)
- Mortality or function stop(1 year after transplantation)
- Number of useless graft team transportation(Immediately after the decision of the transplant team)
- Number of useless graft transportation(Immediately after the decision of the transplant team)
- Use of image transmission by the graft team(Immediately after decision of the transplant team to accept or not the graft)
- Duration of the graft assignment(Immediately after graft assignment)
- Cost of sampling process(Immediately after the sampling process)