Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device

• Conditions: Transplantation, Telemedicine
• Interventions: Device: "After" Group

• Registration Number: NCT03201224
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

In the complex process of organ transplant, two of the major steps are:

1. evaluation of the organs of potential donors in health institutions:

2. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Status Verified: 2018-09
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24
• Primary Completion: 2020-01-01
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group with image transmission	"After" Group	"After" Group

Primary Outcome Measures

Name	Time	Method
Number of successful organ transplantation among those sampled.	3 months after transplantation for kidney, 1 year after transplantation for the other organs

Secondary Outcome Measures

Name	Time	Method
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
Duration of the graft assignment	Immediately after graft assignment
Cost of sampling process	Immediately after the sampling process
Use of image transmission by the graft team	Immediately after decision of the transplant team to accept or not the graft

Trial Locations

Locations (1)

Agence de la biomédecine; 🇫🇷 Saint-Denis, France