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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Transplantation, Telemedicine Device: "After" Group

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
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/Cohort Intervention/treatment
Group without image transmission
"Before" Group
Group with image transmission
"After" Group
Device: "After" Group



Primary Outcome Measures :
  1. Number of successful organ transplantation among those sampled. [ Time Frame: 3 months after transplantation for kidney, 1 year after transplantation for the other organs ]

Secondary Outcome Measures :
  1. Number of assigned organs but not sampled [ Time Frame: Immediately after the decision of the transplant team ]
  2. Number of useless graft transportation [ Time Frame: Immediately after the decision of the transplant team ]
  3. Number of useless graft team transportation [ Time Frame: Immediately after the decision of the transplant team ]
  4. Mortality or function stop [ Time Frame: 1 year after transplantation ]
  5. Duration of the graft assignment [ Time Frame: Immediately after graft assignment ]
  6. Cost of sampling process [ Time Frame: Immediately after the sampling process ]
  7. Use of image transmission by the graft team [ Time Frame: Immediately after decision of the transplant team to accept or not the graft ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All health institutions authorized for organ transplantation in metropolitan France are concerned.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Isabelle Durand-Zaleski, MD, PhD isabelle.durand-zaleski@aphp.fr

Locations
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France
Agence de la biomédecine Recruiting
Saint-Denis, France, 93200
Contact: Hélène Logerot, MD       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         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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Principal Investigator: Isabelle Durand-Zaleski, MD, PhD Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03201224    
Other Study ID Numbers: PREPS - Cristal Images
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No