Transplantation, TelemedicineNCT03201224
Image Transmission Applied to Organ Transplant: Before-after Study of the Effectiveness of the Device
An observational study of Transplantation, Telemedicine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Telemedicine
- What is being tested?
- "After" Group
- Type of treatment
- Medical device
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 31 Mar 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All health institutions authorized for organ transplantation in metropolitan France are concerned.
Who may be able to join
- 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.
Who cannot join
- Donors who died after cardiac arrest
- Donors taken care in a foreign country or outside the Metropolitan France
Trial locations and contacts
1 site in 1 country.
Isabelle Durand-Zaleski, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Agence de la biomédecine
Saint-Denis, 93200
Hélène Logerot, MD, helene.logerot@biomedecine.fr
Hélène Logerot, MD
About this study
Official title: 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.
Read more
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.
- Conditions
- Transplantation, Telemedicine
- Being tested
- "After" Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"After" GroupDevice
| Study group | Role | What they receive |
|---|---|---|
| Group without image transmission | "Before" Group | |
| Group with image transmission | "After" Group Receives: Device: "After" Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful organ transplantation among those sampled.
Measured: 3 months after transplantation for kidney, 1 year after transplantation for the other organs
Secondary outcomes (7)
Number of assigned organs but not sampled
Measured: Immediately after the decision of the transplant team
Number of useless graft transportation
Measured: Immediately after the decision of the transplant team
Number of useless graft team transportation
Measured: Immediately after the decision of the transplant team
Mortality or function stop
Measured: 1 year after transplantation
Duration of the graft assignment
Measured: Immediately after graft assignment
Cost of sampling process
Measured: Immediately after the sampling process
Use of image transmission by the graft team
Measured: Immediately after decision of the transplant team to accept or not the graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jan 2014
- Primary completion1 Jan 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Transplantation, TelemedicineStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Isabelle Durand-Zaleski, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201224
- Sponsor's protocol ID
- PREPS - Cristal Images
- Status last verified
- Sep 2018
- First submitted
- 13 Jun 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 18764835Rosenkrantz 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.
PubMed 25299785Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89.
PubMed 22461345Fregeville 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.
PubMed 20212375Charrier 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.
PubMed 26857558Zarca 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.
PubMed 31533713
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Transmission Applied to Organ Transplant: Before-after Study of the Device of the Effectiveness
- ClinicalTrials.gov ID
- NCT03201224
- Acronym / sponsor ID
- PREPS - Cristal Images
- Conditions
- Transplantation, Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group without image transmission | – | –"Before" Group |
| Group with image transmission | – | Device: "After" Group"After" Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All health institutions authorized for organ transplantation in metropolitan France are concerned.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Donors who died after cardiac arrest
- Donors taken care in a foreign country or outside the Metropolitan France
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "After" Group | Device | Group with image transmission |
Primary outcome
Number of successful organ transplantation among those sampled.
Time frame: 3 months after transplantation for kidney, 1 year after transplantation for the other organs
7 secondary outcomes
Number of assigned organs but not sampled
Time frame: Immediately after the decision of the transplant team
Number of useless graft transportation
Time frame: Immediately after the decision of the transplant team
Number of useless graft team transportation
Time frame: Immediately after the decision of the transplant team
Mortality or function stop
Time frame: 1 year after transplantation
Duration of the graft assignment
Time frame: Immediately after graft assignment
Cost of sampling process
Time frame: Immediately after the sampling process
Use of image transmission by the graft team
Time frame: Immediately after decision of the transplant team to accept or not the graft
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Background: PubMed 18764835Reddy 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.
- Background: PubMed 25299785Rosenkrantz 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.
- Background: PubMed 22461345Furlow B. Solid organ donation and transplantation. Radiol Technol. 2012 Mar-Apr;83(4):371-89.
- Background: PubMed 20212375Fregeville 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.
- Background: PubMed 26857558Charrier 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.
- Derived from this study: PubMed 31533713Zarca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Durand-Zaleski, MD, PhD contact
Isabelle Durand-Zaleski, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris - DRCD URC Eco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation, Telemedicine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Durand-Zaleski, MD, PhD (isabelle.durand-zaleski@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful organ transplantation among those sampled. (time frame: 3 months after transplantation for kidney, 1 year after transplantation for the other organs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201224, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.