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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03201224
Enrollment
20000
Registered
2017-06-28
Start date
2014-01-01
Completion date
2020-03-31
Last updated
2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplantation, Telemedicine

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.

Interventions

DEVICEAfter Group

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Number of useless graft transportationImmediately after the decision of the transplant team
Number of useless graft team transportationImmediately after the decision of the transplant team
Mortality or function stop1 year after transplantation
Number of assigned organs but not sampledImmediately after the decision of the transplant team
Cost of sampling processImmediately after the sampling process
Use of image transmission by the graft teamImmediately after decision of the transplant team to accept or not the graft
Duration of the graft assignmentImmediately after graft assignment

Countries

France

Contacts

Primary ContactIsabelle Durand-Zaleski, MD, PhD
isabelle.durand-zaleski@aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026