DONATE-Pilot Study on ICU Management of Deceased Organ Donors (DONATE-Pilot)
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|ClinicalTrials.gov Identifier: NCT02902783|
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment|
|Deceased Organ Donors Critical Care||Other: Data Collection|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||177 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
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).
Other: Data Collection
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).
- 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.
- Description of current practices [ Time Frame: After 1 year of recruitment at each participating site ]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.
- Effectiveness of various ICU interventions [ Time Frame: After 1 year of recruitment at each participating site ]Defined as: 1) Number of organs recovered; 2) Number of organs transplanted.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902783
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Centre de recherche CHUS|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Study Director:||Meade Maureen, MD, MSc||McMaster University|
|Principal Investigator:||Frederick D'Aragon, MD, MSc||Université de Sherbrooke|