NCT07698262

Brief Summary

The purpose of this study is to develop a new tool that uses information collected before life-sustaining treatments are withdrawn to better predict whether a patient will die within the time needed for organ donation to be possible. The tool created should help improve planning for organ donation and provide families and healthcare teams with more accurate information.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
48mo left

Started Jan 2027

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Predicting organ donation after circulatory deathDCD

Outcome Measures

Primary Outcomes (1)

  • To develop a clinically applicable model to predict dying duration in a cohort of patient eligible for donation after circulatory death

    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.

    The models will be built to predict death within 30, 60 and 120 minutes

Secondary Outcomes (1)

  • Comparison of the brain-to-heart model to existing models

    The models will be compared for death within 30, 60 and 120 minutes

Study Arms (1)

The study cohort will consist of patients eligible for donation after circulatory determination of

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU

You may qualify if:

  • Age ≥ 19;
  • Eligible for DCD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cumming School of Medicine

Calgary, Alberta, Canada

Location

UBC/East Kootenay Regional Hospital

Cranbrook, British Columbia, Canada

Location

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

University of Manitoba Health Sciences Center

Winnipeg, Manitoba, Canada

Location

University Hospital - London Health Sciences Centre

London, Ontario, N6A 3K7, Canada

Location

Lakeridge Health

Oshawa, Ontario, L1G 8A2, Canada

Location

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, Canada

Location

St Paul hospital

Vancouver, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood-based brain biomarkers

Central Study Contacts

Rebecca Grey Clinical Research Coordinator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, UBC Critical Care Medicine

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

July 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data will be avaiable to be shared on demand. However, statistical analysis and prediction modeling computer code will be made publicly available on GitHub.

Locations