- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03201224
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:
- evaluation of the organs of potential donors in health institutions:
- 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Saint-Denis, Frankrig, 93200
- Rekruttering
- Agence de la biomédecine
-
Kontakt:
- Hélène Logerot, MD
- E-mail: helene.logerot@biomedecine.fr
-
Ledende efterforsker:
- Hélène Logerot, MD
-
Ledende efterforsker:
- Huot Olivier, MD
-
Underforsker:
- Laouabdia Karim, MD
-
Underforsker:
- Bastien Olivier, MD, PhD
-
Underforsker:
- Legeai Camille, MD
-
Underforsker:
- Lucas-Samuel Samuel, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Group without image transmission
"Before" Group
|
|
Group with image transmission
"After" Group
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of successful organ transplantation among those sampled.
Tidsramme: 3 months after transplantation for kidney, 1 year after transplantation for the other organs
|
3 months after transplantation for kidney, 1 year after transplantation for the other organs
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of assigned organs but not sampled
Tidsramme: Immediately after the decision of the transplant team
|
Immediately after the decision of the transplant team
|
Number of useless graft transportation
Tidsramme: Immediately after the decision of the transplant team
|
Immediately after the decision of the transplant team
|
Number of useless graft team transportation
Tidsramme: Immediately after the decision of the transplant team
|
Immediately after the decision of the transplant team
|
Mortality or function stop
Tidsramme: 1 year after transplantation
|
1 year after transplantation
|
Duration of the graft assignment
Tidsramme: Immediately after graft assignment
|
Immediately after graft assignment
|
Cost of sampling process
Tidsramme: Immediately after the sampling process
|
Immediately after the sampling process
|
Use of image transmission by the graft team
Tidsramme: Immediately after decision of the transplant team to accept or not the graft
|
Immediately after decision of the transplant team to accept or not the graft
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Isabelle Durand-Zaleski, MD, PhD, Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PREPS - Cristal Images
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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