Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05390060

Conditions

Hypoxia-Ischemia, Brain

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Neuromonitoring

Study Details

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.

Conditions

Hypoxia-Ischemia, Brain

Study ID

NCT05390060

Start date

Oct 27, 2020

Status verified date

Nov, 2023

Completion date

Apr 27, 2025

Anticipated

Primary completion date

Oct 27, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1) Greater than 19 years old post cardiac arrest with a Glasgow Coma Scale of 8 or less
  • 2) Invasive monitoring implemented within 72 hours of cardiac arrest
  • 3) Duration of cardiac arrest greater than 10 minutes.

Exclusion Criteria:

  • 1) Coagulopathy (INR > 1.5, PTT > 40, Platelets < 100x106 per microliter)
  • 2) Current or anticipated use of anticoagulant or antiplatelet medication
  • 3) Target temperature under 35oC; 4) history of severe TBI, intracranial hemorrhage or stroke.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Neuromonitoring arm

Neuromonitoring placed after cardiac arrest

Interventions

Neuromonitoring

Multimodal neuromonitoring encompassing intracranial pressure, brain tissue oxygenation, microdialysis and cerebral blood flow monitoring

Primary outcome measure

  • Oxygen extraction fraction [ Time Frame: Over the first 72 hours ]

Central Contacts and Locations

Central contacts

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-11-29.