Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device
Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Isabelle Durand-Zaleski, MD, PhD
- 邮箱:isabelle.durand-zaleski@aphp.fr
学习地点
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-
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Saint-Denis、法国、93200
- 招聘中
- Agence de la biomédecine
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接触:
- Hélène Logerot, MD
- 邮箱:helene.logerot@biomedecine.fr
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首席研究员:
- Hélène Logerot, MD
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首席研究员:
- Huot Olivier, MD
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副研究员:
- Laouabdia Karim, MD
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副研究员:
- Bastien Olivier, MD, PhD
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副研究员:
- Legeai Camille, MD
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副研究员:
- Lucas-Samuel Samuel, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Donors who died after cardiac arrest
- Donors taken care in a foreign country or outside the Metropolitan France
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Group without image transmission
"Before" Group
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Group with image transmission
"After" Group
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of successful organ transplantation among those sampled.
大体时间:3 months after transplantation for kidney, 1 year after transplantation for the other organs
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3 months after transplantation for kidney, 1 year after transplantation for the other organs
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次要结果测量
结果测量 |
大体时间 |
---|---|
Number of assigned organs but not sampled
大体时间:Immediately after the decision of the transplant team
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Immediately after the decision of the transplant team
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Number of useless graft transportation
大体时间:Immediately after the decision of the transplant team
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Immediately after the decision of the transplant team
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Number of useless graft team transportation
大体时间:Immediately after the decision of the transplant team
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Immediately after the decision of the transplant team
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Mortality or function stop
大体时间:1 year after transplantation
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1 year after transplantation
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Duration of the graft assignment
大体时间:Immediately after graft assignment
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Immediately after graft assignment
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Cost of sampling process
大体时间:Immediately after the sampling process
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Immediately after the sampling process
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Use of image transmission by the graft team
大体时间:Immediately after decision of the transplant team to accept or not the graft
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Immediately after decision of the transplant team to accept or not the graft
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合作者和调查者
调查人员
- 首席研究员:Isabelle Durand-Zaleski, MD, PhD、Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
出版物和有用的链接
一般刊物
- Reddy MS, Bhati C, Neil D, Mirza DF, Manas DM. National Organ Retrieval Imaging System: results of the pilot study. Transpl Int. 2008 Nov;21(11):1036-44. doi: 10.1111/j.1432-2277.2008.00720.x.
- Rosenkrantz AB, Campbell N, Wehrli N, Triolo MJ, Kim S. New OPTN/UNOS classification system for nodules in cirrhotic livers detected with MR imaging: effect on hepatocellular carcinoma detection and transplantation allocation. Radiology. 2015 Feb;274(2):426-33. doi: 10.1148/radiol.14140069. Epub 2014 Oct 7.
- Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89. Erratum In: Radiol Technol. 2012 May-Jun;83(5):446.
- Fregeville A, De Bazelaire C, Zagdanski A, Albiter M, Desgrandchamps F, De Kerviler E. [Value of whole body CTA in the management of brain-dead patients]. J Radiol. 2010 Jan;91(1 Pt 1):37-44. doi: 10.1016/s0221-0363(10)70004-4. French.
- Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
- Zarca K, Dupont JK, Jacoud L, Bulsei J, Huot O, Logerot H, Durand-Zaleski I. Effectiveness and efficiency of teleimaging in the transplantation process: a mixed method protocol. BMC Health Serv Res. 2019 Sep 18;19(1):672. doi: 10.1186/s12913-019-4488-0.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PREPS - Cristal Images
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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"After" Group的临床试验
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Johns Hopkins UniversityNational Institute on Aging (NIA)招聘中
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的
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Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的
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Northern Illinois UniversityUniversity Autonoma de Santo Domingo终止