National Observational Study of Clinical Practices in Deceased Organ Donation (CanadaDONATE)
|ClinicalTrials.gov Identifier: NCT03114436|
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment|
|Deceased Organ Donation Critical Illness Transplantation||Other: Observational Data Collection|
This prospective cohort study enrols consecutive adult deceased organ donors with a waiver of research consent and collects various data related to deceased donor care in the ICU from the time of consent for donation to the time of organ recovery. Clinical data includes donor characteristics, type of donation (after neurological death or cardiocirculatory death), resuscitation methods, cardiopulmonary monitoring techniques, medications, blood work, mechanical ventilation, diagnostic imaging, complications, and methods of death declaration. 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 Canada-DONATE study is designed to develop a national platform for future clinical trials in deceased donor care. The main objectives include:
- Establish specialized organ donation research teams at participating ICUs.
- 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 to improve the conversion of consented donors to actual donors and to improve the number of transplants per donor.
- Produce specific knowledge translation tools that will serve in the future as clinical tools to enhance ICU care and research tools to facilitate RCTs.
|Study Type :||Observational|
|Actual Enrollment :||622 participants|
|Official Title:||Canada-DONATE: National Observational Study of Clinical Practices in Deceased Organ Donation|
|Actual Study Start Date :||August 31, 2016|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
Consented deceased organ donors
Includes neurological determination of death (DND) and by circulatory determination of death (DCD).
Other: Observational Data Collection
All aspects of deceased donor care in the ICU.
- Adherence to national guidelines for deceased donor care [ Time Frame: Duration of deceased donor care in the ICU (1-5 days per donor). ]For each donor, we will measure adherence to multiple recommendations from national guidelines for the management of deceased organ donors.
- Organ donation [ Time Frame: Duration of deceased donor care in the ICU (1-5 days per donor). ]This refers to the conversion of a consented organ donor to an actual organ donor.
- Organ transplantation [ Time Frame: Transplantation may occur from 1-5 days from the time of consent. ]Deceased organ donors can provide up to 8 organ donations each. We will measure the number of transplants that proceed from each consented donor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114436
|Principal Investigator:||Frederick D'Aragon, MD, MSc||Université de Sherbrooke|
|Study Director:||Maureen O Meade, MD, MSc||McMaster University|