Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death (NeuroDCD)
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Rebecca Grey Clinical Research Coordinator
- Phone Number: 68336 604-875-4111
- Email: cerebri.research@ubc.ca
Study Locations
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Vancouver, Canada
- St Paul Hospital
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Contact:
- John Boyd, MD
- Phone Number: 63047 604-682-2344
- Email: john.boyd@hli.ubc.ca
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Principal Investigator:
- Boyd John, MD
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Alberta
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Calgary, Alberta, Canada
- Cumming School of Medicine
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Contact:
- Julie Kromm, MD
- Phone Number: 403.944.2334
- Email: julie.kromm@ucalgary.ca
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British Columbia
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Cranbrook, British Columbia, Canada
- UBC/East Kootenay Regional Hospital
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Principal Investigator:
- Denise Jaworsky, MD
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Contact:
- Denise Jaworsky, MD
- Phone Number: 250-615-5088
- Email: denise.jaworsky@ubc.ca
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Kelowna, British Columbia, Canada
- Kelowna General Hospital
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Contact:
- Benjamin Wierstra, MD
- Phone Number: 250-862-4000
- Email: bt.wierstra@me.com
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Principal Investigator:
- Benjamin Wierstra, MD
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New Westminster, British Columbia, Canada
- Royal Columbian Hospital
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Contact:
- Andrew Wormsbecker, MD
- Phone Number: 604-520-4253
- Email: Andrew.wormsbecker@fraserhealth.ca
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Principal Investigator:
- Andrew Wormsbecker, MD
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Surrey, British Columbia, Canada
- Surrey Memorial Hospital
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Principal Investigator:
- Anish Mitra, MD
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Contact:
- Anish Mitra, MD
- Phone Number: (604) 581-2211
- Email: anish.mitra@fraserhealth.ca
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Vancouver, British Columbia, Canada, V5Z1M9
- Vancouver General Hospital
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Contact:
- Mypinder Sekhon, MD, PhD
- Phone Number: 604-875-5949
- Email: myp@mail.ubc.ca
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Principal Investigator:
- Mypinder Sekhon, MD, PhD
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Manitoba
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Winnipeg, Manitoba, Canada
- University of Manitoba Health Sciences Center
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Contact:
- Gloria Vazquez-Grande, MD
- Phone Number: +1 800-432-1960
- Email: Gloria.Vazquez-Grande@umanitoba.ca
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Ontario
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London, Ontario, Canada, N6A 3K7
- University Hospital - London Health Sciences Centre
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Contact:
- Marat Slessarev, MD
- Phone Number: 519-685-8500
- Email: marat.slessarev@lhsc.on.ca
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Oshawa, Ontario, Canada, L1G 8A2
- Lakeridge Health
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Principal Investigator:
- Shannon Fernando, MD
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Contact:
- Shannon Fernando, MD
- Phone Number: 6335 (613) 549-6666
- Email: sfernando@lh.ca
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Ottawa, Ontario, Canada
- Children's Hospital of Eastern Ontario (CHEO)
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Contact:
- Sonny Dhanani, MD
- Phone Number: 3670 613-737-7600
- Email: sdhanani@cheo.on.ca613-737-7600
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Principal Investigator:
- Sonny Dhanani, MD
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 19;
- Eligible for DCD
Exclusion Criteria:
Exclusion criteria will consist of :
- concurrent vasopressor doses of norepinephrine >0.05 mcg/kg/min (or dose equivalent)
- PaO2/FiO2 ratio <150 mmHg
- complete high cervical spinal cord injury (C5 and above)
- cardiac support devices (e.g., ECMO, balloon pump, ventricular assist device)
- pacemaker in situ
- tracheostomy
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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The study cohort will consist of patients eligible for donation after circulatory determination of
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To develop a clinically applicable model to predict dying duration in a cohort of patient eligible for donation after circulatory death
Time Frame: The models will be built to predict death within 30, 60 and 120 minutes
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Specifically, we aim at assessing the predictive ability of blood-based brain biomarkers, optic nerve sheet diameter as measured by head computed tomography (CT) scans as a surrogate of intracranial pressure and autonomic dysfunction as reflected by abnormal heart rate variability (HRV) to predict the dying duration.
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The models will be built to predict death within 30, 60 and 120 minutes
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of the brain-to-heart model to existing models
Time Frame: The models will be compared for death within 30, 60 and 120 minutes
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Our secondary aim will be to compare the created models with available models (e.g., DCD-N, UNOS, Wisconsin) and to physician gestalt
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The models will be compared for death within 30, 60 and 120 minutes
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- H25-03465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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