Clinical trial NCT03201224: Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device
Official title: Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transplantation, Telemedicine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-06-28
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All health institutions authorized for organ transplantation in metropolitan France are concerned.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of successful organ transplantation among those sampled.
timeFrame: 3 months after transplantation for kidney, 1 year after transplantation for the other organs
Secondary outcomes:
measure: Number of assigned organs but not sampled
timeFrame: Immediately after the decision of the transplant team
measure: Number of useless graft transportation
timeFrame: Immediately after the decision of the transplant team
measure: Number of useless graft team transportation
timeFrame: Immediately after the decision of the transplant team
measure: Mortality or function stop
timeFrame: 1 year after transplantation
measure: Duration of the graft assignment
timeFrame: Immediately after graft assignment
measure: Cost of sampling process
timeFrame: Immediately after the sampling process
measure: Use of image transmission by the graft team
timeFrame: Immediately after decision of the transplant team to accept or not the graft
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Agence de la biomédecine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
name: Isabelle Durand-Zaleski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89.
citation: 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.
citation: 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.
citation: 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.