Organ DonationCANEVASNCT02854267
Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin
An observational study of Organ Donation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Organ Donation
- How many people
- 322 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Interviews with next of kins as a part of organ donation
Who may be able to join
- situation of confirmed brain dead patient, or dead patient with pending confirmation of brain death
Who cannot join
- situations where the next of kins are met before brain death
Trial locations and contacts
1 site in 1 country.
About this study
A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings
Read the detailed description
The main obstacle for organ procurement in brain dead patients in France is organ donation refusal by the next of kin. When refusal is reflecting the patient's position, ending the organ donation procedure respects the bioethic French laws. Nevertheless, the actual position of the deceased patient often remains unknown. In these cases, organ donation refusal does not necessarily respect the deceased wishes. Many factors have been associated to next of kin organ donation refusal in such situations. Among those factors, some concerning the meeting with the next of kin have been isolated. French data on this subject are lacking.
A dedicated guide for the conduct of meetings with the next of kin has been elaborated by a working group of our network. Its diffusion will take place last quarter of 2016. The purpose of our study is to evaluate its usefulness through an observational multicenter before-after study, concerning every situation of brain dead patient where the next of kin are met by the medical staff. The refusal rate will be assessed over the first period (before the diffusion of the guide), from july 2012 to june 2014, and compared to that assessed over the second period (after the diffusion of the guide) from january 2017 to december 2018, using the national database of Biomedicine Agency. A comparison of this change in refusal rate will be made between centers of our network and the remaining centers in France nationwide. Anxiety of professionals will be assessed prospectively after each meeting conducted in one of our network centers, over 2 periods, before (from July to October 2016) and after (starting in january 2017) the diffusion of the dedicated guide for the conduct of the meeting with the next of kin. Compliance to the guide by the physicians and organ procurement nurses will be assessed after its diffusion in the centers of our network.
- Conditions
- Organ Donation
- Keywords
- organ procurement, brain death, organ donation, next of kins
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group without guide, before guide's diffusion | For this group, only the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database; The group without guide is made up by all registered situations of brain death patients on the database (nationwide) minus the situations occuring in the group with guide (22 intensive care units forming the 'RESEAU NORD FRANCILIEN' network). The period before the diffusion of the guide is from 1st of july 2012 to 30th of june 2014 | |
| group without guide, after guide's diffusion | For this group, only the primary objective (refusal rate) will be assessed, using the French Biomedicine Agency database; The group without guide is made up by all the registered situations of brain death patients on the database minus the situations occuring in the group with guide ('RESEAU NORD FRANCILIEN'). The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018 | |
| Group with guide, before guide's diffusion | For this group, only the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database; The group with guide is made up by all the registered situations of brain death patients on the database occuring in the 22 intensive care unit forming the 'RESEAU NORD FRANCILIEN' network. The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018. | |
| Group with guide, after guide's diffusion | For this group, the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database. The secondary endpoints (level of anxiety of the caregivers before the meeting with the next of kins as measured by the french short version of Spielberger test and compliance to the guide) will be assessed by the datasheet prospectively filled by the caregivers. The group with guide is made up by all the registered situations of brain death patients on the database occuring in the 22 intensive care unit forming the 'RESEAU NORD FRANCILIEN' network. The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refusal to organ procurement as expressed by next of kins
Assessed in the national biomedicine agency database retrospectively over a 2-years period before diffusion of a dedicated guide for meeting, and prospectively over a 2 years period after the diffusion of a dedicated guide for meeting
Measured: 2 years
Secondary outcomes (2)
Anxiety level of caregivers after meeting with the next of kins
The anxiety will be measured by the short French version of the Spielberger anxiety state scale, and assessed prospectively over 2 periods, before and after the diffusion of a dedicated guide for meeting
Measured: 2 years
Compliance to the guide
The compliance will be measured though a debriefing form filled by the caregivers after each meeting with the next of kins
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ DonationStudies 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas Kandelman, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854267
- Sponsor's protocol ID
- CANEVAS
- Acronym
- CANEVAS
- Status last verified
- Jan 2020
- First submitted
- 31 Jul 2016
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin
- ClinicalTrials.gov ID
- NCT02854267
- Acronym / sponsor ID
- CANEVAS / CANEVAS
- Conditions
- Organ Donation
- Keywords
- organ procurement, brain death, organ donation, next of kins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings
Detailed description
The main obstacle for organ procurement in brain dead patients in France is organ donation refusal by the next of kin. When refusal is reflecting the patient's position, ending the organ donation procedure respects the bioethic French laws. Nevertheless, the actual position of the deceased patient often remains unknown. In these cases, organ donation refusal does not necessarily respect the deceased wishes. Many factors have been associated to next of kin organ donation refusal in such situations. Among those factors, some concerning the meeting with the next of kin have been isolated. French data on this subject are lacking.
A dedicated guide for the conduct of meetings with the next of kin has been elaborated by a working group of our network. Its diffusion will take place last quarter of 2016. The purpose of our study is to evaluate its usefulness through an observational multicenter before-after study, concerning every situation of brain dead patient where the next of kin are met by the medical staff. The refusal rate will be assessed over the first period (before the diffusion of the guide), from july 2012 to june 2014, and compared to that assessed over the second period (after the diffusion of the guide) from january 2017 to december 2018, using the national database of Biomedicine Agency. A comparison of this change in refusal rate will be made between centers of our network and the remaining centers in France nationwide. Anxiety of professionals will be assessed prospectively after each meeting conducted in one of our network centers, over 2 periods, before (from July to October 2016) and after (starting in january 2017) the diffusion of the dedicated guide for the conduct of the meeting with the next of kin. Compliance to the guide by the physicians and organ procurement nurses will be assessed after its diffusion in the centers of our network.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group without guide, before guide's diffusion | – | –For this group, only the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database; The group without guide is made up by all registered situations of brain death patients on the database (nationwide) minus the situations occuring in the group with guide (22 intensive care units forming the 'RESEAU NORD FRANCILIEN' network). The period before the diffusion of the guide is from 1st of july 2012 to 30th of june 2014 |
| group without guide, after guide's diffusion | – | –For this group, only the primary objective (refusal rate) will be assessed, using the French Biomedicine Agency database; The group without guide is made up by all the registered situations of brain death patients on the database minus the situations occuring in the group with guide ('RESEAU NORD FRANCILIEN'). The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018 |
| Group with guide, before guide's diffusion | – | –For this group, only the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database; The group with guide is made up by all the registered situations of brain death patients on the database occuring in the 22 intensive care unit forming the 'RESEAU NORD FRANCILIEN' network. The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018. |
| Group with guide, after guide's diffusion | – | –For this group, the primary endpoint (refusal rate) will be assessed, using the French Biomedicine Agency database. The secondary endpoints (level of anxiety of the caregivers before the meeting with the next of kins as measured by the french short version of Spielberger test and compliance to the guide) will be assessed by the datasheet prospectively filled by the caregivers. The group with guide is made up by all the registered situations of brain death patients on the database occuring in the 22 intensive care unit forming the 'RESEAU NORD FRANCILIEN' network. The period after the diffusion of the guide is from 1st of january 2017 to 31st of december 2018 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Interviews with next of kins as a part of organ donation
Key inclusion criteria (1 listed)
- situation of confirmed brain dead patient, or dead patient with pending confirmation of brain death
Key exclusion criteria (1 listed)
- situations where the next of kins are met before brain death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Refusal to organ procurement as expressed by next of kins
Time frame: 2 years
Assessed in the national biomedicine agency database retrospectively over a 2-years period before diffusion of a dedicated guide for meeting, and prospectively over a 2 years period after the diffusion of a dedicated guide for meeting
2 secondary outcomes
Anxiety level of caregivers after meeting with the next of kins
Time frame: 2 years
Compliance to the guide
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Stanislas Kandelman, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Organ Donation, 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 1 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: finished, as of the sponsor's last update on 28 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refusal to organ procurement as expressed by next of kins (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2020.