Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device
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|ClinicalTrials.gov Identifier: NCT03201224|
Recruitment Status : Unknown
Verified September 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : June 28, 2017
Last Update Posted : April 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Transplantation, Telemedicine||Device: "After" Group|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||20000 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness|
|Actual Study Start Date :||January 1, 2014|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Group without image transmission
Group with image transmission
Device: "After" Group
- Number of successful organ transplantation among those sampled. [ Time Frame: 3 months after transplantation for kidney, 1 year after transplantation for the other organs ]
- Number of assigned organs but not sampled [ Time Frame: Immediately after the decision of the transplant team ]
- Number of useless graft transportation [ Time Frame: Immediately after the decision of the transplant team ]
- Number of useless graft team transportation [ Time Frame: Immediately after the decision of the transplant team ]
- Mortality or function stop [ Time Frame: 1 year after transplantation ]
- Duration of the graft assignment [ Time Frame: Immediately after graft assignment ]
- Cost of sampling process [ Time Frame: Immediately after the sampling process ]
- Use of image transmission by the graft team [ Time Frame: Immediately after decision of the transplant team to accept or not the graft ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201224
|Contact: Isabelle Durand-Zaleski, MD, PhDfirstname.lastname@example.org|
|Agence de la biomédecine||Recruiting|
|Saint-Denis, France, 93200|
|Contact: Hélène Logerot, MD email@example.com|
|Principal Investigator: Hélène Logerot, MD|
|Principal Investigator: Huot Olivier, MD|
|Sub-Investigator: Laouabdia Karim, MD|
|Sub-Investigator: Bastien Olivier, MD, PhD|
|Sub-Investigator: Legeai Camille, MD|
|Sub-Investigator: Lucas-Samuel Samuel, MD|
|Principal Investigator:||Isabelle Durand-Zaleski, MD, PhD||Assistance Publique - Hôpitaux de Paris - DRCD URC Eco|