Organ DonationNCT03612024
Bernese Next of Kin Survey Following Organ Donation Request
An observational study of Organ Donation and Next of Kin, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
6 to 18 months after organ donation request a next of kin survey using a standardized questionnaire was conducted. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Organ Donation, Next of Kin, Post Traumatic Stress Disorder
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 117 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2018to 24 Jul 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Next of kin involved in request for organ donation. Single center study. The request for organ donation must have passed 6 to 18 months ago
Who may be able to join
- Next of kin involved in request for organ donation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Next of Kin Survey Following Organ Donation Request - a Single Center Experience
6 to 18 months after organ donation request a next of kin survey using a standardized questionnaire was conducted.
- Conditions
- Organ Donation, Next of Kin, Post Traumatic Stress Disorder
- Being tested
- questionnaire
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
a standardized questionnaire was sent to all participants
| Study group | Role | What they receive |
|---|---|---|
| request for organ donation approved | Not described Receives: Behavioral: questionnaire | |
| request for organ donation rejected | Not described Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
factors influencing approval/rejection of an organ donation
Measured: 6 to 18 months pre questionnaire
factors with influence on mourning porcess
Measured: 6 to 18 months past request
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Mar 2018
- Primary completion1 Jul 2018
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ DonationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Bloch, Insel Gruppe AG, University Hospital Bern
- Investigators
- Andreas Bloch, MD, Principal investigator, department of critical care medicine, inselspital, university hospital, bern, university of bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612024
- Sponsor's protocol ID
- BNoKSurvey FODR
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nebiker M, Bloch A, Fedakar P, Christen L, Hurni A, Carre D, Cluzet S, Eckert P, Schefold JC. Organ donation in the ICU - a survey on next of kin response in two Swiss academic centres. Swiss Med Wkly. 2021 Jun 23;151:w20515. doi: 10.4414/smw.2021.20515. eCollection 2021 Jun 21.
PubMed 34161597
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next of Kin Survey Following Organ Donation Request - a Single Center Experience
- ClinicalTrials.gov ID
- NCT03612024
- Acronym / sponsor ID
- BNoKSurvey FODR
- Conditions
- Organ Donation, Next of Kin, Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 2 Aug 2018 (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.
6 to 18 months after organ donation request a next of kin survey using a standardized questionnaire was conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| request for organ donation approved | – | Behavioral: questionnaire |
| request for organ donation rejected | – | Behavioral: questionnaire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Next of kin involved in request for organ donation. Single center study. The request for organ donation must have passed 6 to 18 months ago
Key inclusion criteria (1 listed)
- Next of kin involved in request for organ donation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| questionnairea standardized questionnaire was sent to all participants | Behavioural | request for organ donation approved, request for organ donation rejected |
Primary outcome
factors influencing approval/rejection of an organ donation
Time frame: 6 to 18 months pre questionnaire
factors with influence on mourning porcess
Time frame: 6 to 18 months past request
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 31 Aug 2018.
- Derived from this study: PubMed 34161597Nebiker M, Bloch A, Fedakar P, Christen L, Hurni A, Carre D, Cluzet S, Eckert P, Schefold JC. Organ donation in the ICU - a survey on next of kin response in two Swiss academic centres. Swiss Med Wkly. 2021 Jun 23;151:w20515. doi: 10.4414/smw.2021.20515. eCollection 2021 Jun 21.
- 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.
Andreas Bloch, MD principal investigator
department of critical care medicine, inselspital, university hospital, bern, university of bern
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 and Next of Kin, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 0 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 31 Aug 2018. 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 Switzerland. 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?
factors influencing approval/rejection of an organ donation (time frame: 6 to 18 months pre questionnaire). The study lists 2 primary outcomes in all. 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 NCT03612024, which also lists 1 linked publication.
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 31 Aug 2018.