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Neuromonitoring for Hypoxic-Ischemic Brain Injury (DIFFUSION Trial)

N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Greater than 19 years old post cardiac arrest with a Glasgow Coma Scale of 8 or less
Duration of cardiac arrest greater than 10 minutes.
Must not have
Current or anticipated use of anticoagulant or antiplatelet medication
History of severe TBI, intracranial hemorrhage or stroke.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post arrest
Awards & highlights

Summary

This trial evaluates how well oxygen gets from the blood into the brain in patients who have had a cardiac arrest. It focuses on patients with brain injury due to lack of oxygen, checking both blood flow and oxygen movement into brain cells, as well as looking at markers for brain injury and inflammation.

Who is the study for?
This trial is for adults over 19 who've had a cardiac arrest lasting more than 10 minutes and are in a coma or have severe brain function impairment. They must be able to receive invasive monitoring within 72 hours of the event. People with blood clotting issues, on certain blood thinners, or with past severe brain injuries or strokes can't participate.
What is being tested?
The study aims to understand why some patients can't get enough oxygen into their brains after a cardiac arrest by using advanced neuromonitoring techniques. It will compare those with normal and abnormal oxygen transport to find out what's causing these differences.
What are the potential side effects?
Since this trial involves neuromonitoring rather than medication, side effects may include discomfort from the monitoring equipment or risks associated with invasive procedures used for monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 19 and have a low consciousness level after a cardiac arrest.
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My heart has stopped for more than 10 minutes before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently using or plan to use blood thinners.
Select...
I have had a severe brain injury, bleeding in the brain, or a stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post arrest
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post arrest for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxygen extraction fraction
Secondary study objectives
Brain biomarker serum concentrations
Clinical outcome at 6 months
Lactate to pyruvate ratio
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neuromonitoring armExperimental Treatment1 Intervention
Neuromonitoring placed after cardiac arrest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuromonitoring
2012
N/A
~400

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,150 Total Patients Enrolled

Media Library

Neuromonitoring Clinical Trial Eligibility Overview. Trial Name: NCT05390060 — N/A
Hypoxic-Ischemic Brain Injury Research Study Groups: Neuromonitoring arm
Hypoxic-Ischemic Brain Injury Clinical Trial 2023: Neuromonitoring Highlights & Side Effects. Trial Name: NCT05390060 — N/A
Neuromonitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT05390060 — N/A
~1 spots leftby Oct 2024
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