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:

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.

Study Overview

• Status: Unknown
• Conditions: Transplantation, Telemedicine
• Intervention / Treatment: Device: "After" Group

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

Study Locations

• France
  • Saint-Denis, France, 93200
    • Recruiting
    • Agence de la biomédecine
    • Contact: Hélène Logerot, MD; Email: helene.logerot@biomedecine.fr
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All health institutions authorized for organ transplantation in metropolitan France are concerned.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group without image transmission; "Before" Group
Group with image transmission; "After" Group	Device: "After" Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of assigned organs but not sampled	Immediately after the decision of the transplant team
Number of useless graft transportation	Immediately after the decision of the transplant team
Number of useless graft team transportation	Immediately after the decision of the transplant team
Mortality or function stop	1 year after transplantation
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, Assistance Publique - Hôpitaux de Paris - DRCD URC Eco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PREPS - Cristal Images

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No