Delineating Between Pathophysiologic Phenotypes of Hypoxic Ischemic Brain Injury After Cardiac Arrest
DIFFUSION
1 other identifier
interventional
40
1 country
1
Brief Summary
The main outcome determinant following cardiac arrest is hypoxic ischemic brain injury. Management has involved increasing the delivery of oxygen to the brain. This logic assumes that oxygen transport from blood into the brain is normal. We have demonstrated that this assumption is not true. A large proportion of post-cardiac arrest patients demonstrate an inability to unload oxygen into the brain. The mechanisms explaining this observation are unclear. This project involves using a series of evaluations to differentiate post-cardiac arrest patients who exhibit normal and abnormal oxygen transport dynamics and also investigate the underlying mechanisms for abnormal oxygen transport.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedFirst Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2025
CompletedNovember 29, 2023
November 1, 2023
4 years
May 16, 2022
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygen extraction fraction
The fraction of oxygen which is extracted into the brain
Over the first 72 hours
Secondary Outcomes (4)
Venous to brain tissue oxygen tension gradient
Over the first 72 hours
Brain biomarker serum concentrations
Over the first 72 hours
Lactate to pyruvate ratio
Over the first 72 hours
Clinical outcome at 6 months
6 months post arrest
Study Arms (1)
Neuromonitoring arm
EXPERIMENTALNeuromonitoring placed after cardiac arrest
Interventions
Multimodal neuromonitoring encompassing intracranial pressure, brain tissue oxygenation, microdialysis and cerebral blood flow monitoring
Eligibility Criteria
You may qualify if:
- \) Greater than 19 years old post cardiac arrest with a Glasgow Coma Scale of 8 or less
- \) Invasive monitoring implemented within 72 hours of cardiac arrest
- \) Duration of cardiac arrest greater than 10 minutes.
You may not qualify if:
- \) Coagulopathy (INR \> 1.5, PTT \> 40, Platelets \< 100x106 per microliter)
- \) Current or anticipated use of anticoagulant or antiplatelet medication
- \) Target temperature under 35oC; 4) history of severe TBI, intracranial hemorrhage or stroke.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 25, 2022
Study Start
October 27, 2020
Primary Completion
October 27, 2024
Study Completion
April 27, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11