Deceased Organ DonorsDONATE-PilotNCT02902783
DONATE-Pilot Study on ICU Management of Deceased Organ Donors
An observational study of Deceased Organ Donors and Critical Care, run by McMaster University at 2 sites in Canada.
Trial summary
The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that observes the ICU management of consented deceased organ donors at 4 high volume centres over a period of 12 months each. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deceased Organ Donors, Critical Care
- What is being tested?
- Data Collection
- How many people
- 177 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2015to Mar 2017
- How long will I take part?
- 12 Months
- 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: All patients for whom consent for deceased organ donation has been obtained.
Who may be able to join
- Admitted to a critical care area (ICU, PICU, CCU, ER)
- Consented deceased organ donors (DND and DCD)
Who cannot join
- Neonate <36 weeks gestation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Centre de recherche CHUS
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors
The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that observes the ICU management of consented deceased organ donors at 4 high volume centres over a period of 12 months each. The pilot study will be followed by a 1-year prospective national observational study a 15-20 ICUs across Canada.
Read the detailed description
This prospective observational cohort pilot study enrols consented organ donors admitted to 4 high volume centres over a period of 12 months. Various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery.
The main objectives of the DONATE-Pilot reflect the objectives of the national study which correspond to the steps in developing a platform for future clinical trials.
- Form research teams at participating ICUs that will include an ICU physician-researcher, a local organ donation champion, ICU research coordinators and (in a limited role) a local coordinator from the provincial Organ Donation Organization (ODO);
- Observe, record, and describe ICU practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future RCTs.
- Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
- Investigate the comparative effectiveness of various ICU interventions in deceased donor care (e.g. the potential for hormonal therapies to improve transplant rates, the potential of heparin therapy to improve peri-operative graft function);
- Produce specific knowledge translation tools that will serve in the future as both clinical tools to enhance ICU care and research tools to facilitate future RCTs.
As part of the DONATE-Pilot we also aim to assess feasibility. Specifically the objectives are to:
- Refine data collection procedures for deceased donors in ICU;
- Estimate time requirements for data collection;
- Develop efficient links to post-transplantation data and;
- Share data as it accrues with clinicians.
- Conditions
- Deceased Organ Donors, Critical Care
- Being tested
- Data Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Data collection relevant to this study will be obtained by observation and review of hospital charts. Limited data will be obtained through relevant organ donation organizations (ODOs).
| Study group | Role | What they receive |
|---|---|---|
| Consented deceased organ donors | Data will be collected on deceased donors, declared by neurological determination of death (DND) and by circulatory determination of death (DCD). Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
This outcome is judged based on four elements: 1) Implementation of a waived consent model; 2) Refinement of data collection procedures for adult intensive care units; 3) Development of efficient links to post-transplantation data.
Measured: After 1 year of recruitment at each participating site
Secondary outcomes (2)
Description of current practices
A descriptive analysis of various interventions and approaches in the management of deceased organ donors. Adherence to recommendations of the national deceased donor management guidelines.
Measured: After 1 year of recruitment at each participating site
Effectiveness of various ICU interventions
Defined as: 1) Number of organs recovered; 2) Number of organs transplanted.
Measured: After 1 year of recruitment at each participating site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionMar 2017
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 Deceased Organ DonorsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- 177 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Canadian National Transplant Research Program
- Responsible party
- Sponsor
- Investigators
- Meade Maureen, MD, MSc, Study director, McMaster UniversityFrederick D'Aragon, MD, MSc, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902783
- Sponsor's protocol ID
- DONATE-Pilot 14-803
- Acronym
- DONATE-Pilot
- Status last verified
- Feb 2018
- First submitted
- 7 Sep 2016
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
D'Aragon F, Cook D, Dhanani S, Ribic C, Burns KEA, Akhtar A, Hand L, Arseneau E, Cupido C, Whittigham H, Healey A, Frenette AJ, Lamontagne F, Meade MO; Canadian Critical Care Trials Group and the Canadian National Transplant Research Program. Hamilton-DONATE: a city-wide pilot observational study of the ICU management of deceased organ donors. Can J Anaesth. 2018 Oct;65(10):1110-1119. doi: 10.1007/s12630-018-1179-y. Epub 2018 Jul 9.
PubMed 29987806
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors
- ClinicalTrials.gov ID
- NCT02902783
- Acronym / sponsor ID
- DONATE-Pilot / DONATE-Pilot 14-803
- Conditions
- Deceased Organ Donors, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Canadian National Transplant Research Program
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Sep 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.
The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that observes the ICU management of consented deceased organ donors at 4 high volume centres over a period of 12 months each. The pilot study will be followed by a 1-year prospective national observational study a 15-20 ICUs across Canada.
Detailed description
This prospective observational cohort pilot study enrols consented organ donors admitted to 4 high volume centres over a period of 12 months. Various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery.
The main objectives of the DONATE-Pilot reflect the objectives of the national study which correspond to the steps in developing a platform for future clinical trials.
- Form research teams at participating ICUs that will include an ICU physician-researcher, a local organ donation champion, ICU research coordinators and (in a limited role) a local coordinator from the provincial Organ Donation Organization (ODO);
- Observe, record, and describe ICU practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future RCTs.
- Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
- Investigate the comparative effectiveness of various ICU interventions in deceased donor care (e.g. the potential for hormonal therapies to improve transplant rates, the potential of heparin therapy to improve peri-operative graft function);
- Produce specific knowledge translation tools that will serve in the future as both clinical tools to enhance ICU care and research tools to facilitate future RCTs.
As part of the DONATE-Pilot we also aim to assess feasibility. Specifically the objectives are to:
- Refine data collection procedures for deceased donors in ICU;
- Estimate time requirements for data collection;
- Develop efficient links to post-transplantation data and;
- Share data as it accrues with clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consented deceased organ donors | – | Other: Data CollectionData will be collected on deceased donors, declared by neurological determination of death (DND) and by circulatory determination of death (DCD). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients for whom consent for deceased organ donation has been obtained.
Key inclusion criteria (2 listed)
- Admitted to a critical care area (ICU, PICU, CCU, ER)
- Consented deceased organ donors (DND and DCD)
Key exclusion criteria (1 listed)
- Neonate <36 weeks gestation
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 |
|---|---|---|
| Data CollectionData collection relevant to this study will be obtained by observation and review of hospital charts. Limited data will be obtained through relevant organ donation organizations (ODOs). | Other | Consented deceased organ donors |
Primary outcome
Feasibility
Time frame: After 1 year of recruitment at each participating site
This outcome is judged based on four elements: 1) Implementation of a waived consent model; 2) Refinement of data collection procedures for adult intensive care units; 3) Development of efficient links to post-transplantation data.
2 secondary outcomes
Description of current practices
Time frame: After 1 year of recruitment at each participating site
Effectiveness of various ICU interventions
Time frame: After 1 year of recruitment at each participating site
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 26 Mar 2018.
- Derived from this study: PubMed 29987806D'Aragon F, Cook D, Dhanani S, Ribic C, Burns KEA, Akhtar A, Hand L, Arseneau E, Cupido C, Whittigham H, Healey A, Frenette AJ, Lamontagne F, Meade MO; Canadian Critical Care Trials Group and the Canadian National Transplant Research Program. Hamilton-DONATE: a city-wide pilot observational study of the ICU management of deceased organ donors. Can J Anaesth. 2018 Oct;65(10):1110-1119. doi: 10.1007/s12630-018-1179-y. Epub 2018 Jul 9.
- DONATE Reseearch Progam WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Meade Maureen, MD, MSc study director
McMaster University
Frederick D'Aragon, MD, MSc principal investigator
Université de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deceased Organ Donors and Critical Care, run by McMaster University at 2 sites in Canada.
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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Feasibility (time frame: After 1 year of recruitment at each participating site). 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 NCT02902783, 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 26 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.