Brain DeathNCT04303624
Understanding Family Refusal
An observational study of Brain Death and Renal Failure, run by Yale-NUS College.
Trial summary
The investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Death, Renal Failure
- What is being tested?
- Health sciences survey
- How many people
- 1,007 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Mar 2019
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were a representative sample of Singapore's population, approached via door-to-door recruitment and via community eateries.
Who may be able to join
- Citizens or permanent residents of Singapore
- Above 21
Who cannot join
- Below 21
About this study
Official title: Exploring Family vs. Individual Decision-making in Organ Donation
The investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation.
- Conditions
- Brain Death, Renal Failure
- Being tested
- Health sciences survey
- Keywords
- Organ donation, Transplantation, Intensive care
- Medical subject headings
- Brain Death, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health sciences surveyOther
Large scale demographic survey evaluating attitudes of population towards organ donation for the self vs. family
| Study group | Role | What they receive |
|---|---|---|
| Community sample | Representative sample of the Singapore population Receives: Other: Health sciences survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to donate
Participants indicated their willingness to donate their own organs and those of a close family member
Measured: Single measurement (time of taking the survey)
Secondary outcomes (1)
Confidence in family decision-making
Participants rated how confident they were that - upon their family member's death - they would respect their family member's views regarding donation rated using 5-point scales anchored on one end with 1="Not confident at all" and 5="Absolutely confident").
Measured: Single measurement (time of taking the survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Sep 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Principal investigator, Jean Liu, Yale-NUS College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303624
- Sponsor's protocol ID
- HSS-1502-P02-06
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to stipulations by the Institutional Review Board, there is no data that can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Family vs. Individual Decision-making in Organ Donation
- ClinicalTrials.gov ID
- NCT04303624
- Acronym / sponsor ID
- HSS-1502-P02-06
- Conditions
- Brain Death, Renal Failure
- Keywords
- Organ donation, Transplantation, Intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 11 Mar 2020 (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.
The investigators plan a secondary data analysis of an existing dataset to examine how individual decision-making differs from family decision-making in organ donation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community sample | – | Other: Health sciences surveyRepresentative sample of the Singapore population |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were a representative sample of Singapore's population, approached via door-to-door recruitment and via community eateries.
Key inclusion criteria (2 listed)
- Citizens or permanent residents of Singapore
- Above 21
Key exclusion criteria (1 listed)
- Below 21
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 |
|---|---|---|
| Health sciences surveyLarge scale demographic survey evaluating attitudes of population towards organ donation for the self vs. family | Other | Community sample |
Primary outcome
Willingness to donate
Time frame: Single measurement (time of taking the survey)
Participants indicated their willingness to donate their own organs and those of a close family member
1 secondary outcome
Confidence in family decision-making
Time frame: Single measurement (time of taking the survey)
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 11 Mar 2020.
- Individual participant dataSharing planned: No. Due to stipulations by the Institutional Review Board, there is no data that can be shared.
Related trials for Brain Death
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Study of the Link Between Structural Alterations in the Hypothalamus and Cardiac Dysautonomia in Drug-resistant Epilepsy
Epilepsy, Hypothalamus
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death and Renal Failure, run by Yale-NUS College.
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 2 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Willingness to donate (time frame: Single measurement (time of taking the survey)). 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 11 Mar 2020.