DONATE-Pilot Study on ICU Management of Deceased Organ Donors

Critical Care Clinical Trial

— DONATE-Pilot  

Official title:

DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902783
• Other study ID #: DONATE-Pilot 14-803
• Status: Completed
• First received: September 7, 2016
• Last updated: March 22, 2018
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The pilot study will be followed by a 1-year prospective national observational study a 15-20 ICUs across Canada.

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.

1. 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);

2. 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.

3. Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.

4. 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);

5. 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:

1. Refine data collection procedures for deceased donors in ICU;

2. Estimate time requirements for data collection;

3. Develop efficient links to post-transplantation data and;

4. Share data as it accrues with clinicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Admitted to a critical care area (ICU, PICU, CCU, ER)

• Consented deceased organ donors (DND and DCD)

Exclusion Criteria:

• Neonate <36 weeks gestation

Related Conditions & MeSH terms

• Critical Care
• Death
• Deceased Organ Donors

Intervention

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).

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Centre de recherche CHUS	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Critical Care Trials Group, Canadian National Transplant Research Program

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 1 year of recruitment at each participating site
Secondary	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.	After 1 year of recruitment at each participating site
Secondary	Effectiveness of various ICU interventions	Defined as: 1) Number of organs recovered; 2) Number of organs transplanted.	After 1 year of recruitment at each participating site

External Links

•   DONATE Reseearch Progam Website