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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 is testing whether or not oxygen transport to the brain is normal in post-cardiac arrest patients, and if not, what the underlying mechanisms are.
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.Check my eligibility
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.See study design
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 belowSelect...
I am over 19 and have a low consciousness level after a cardiac arrest.
Select...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post arrest
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post arrest
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen extraction fraction
Secondary outcome measures
Brain biomarker serum concentrations
Clinical outcome at 6 months
Lactate to pyruvate ratio
+1 moreTrial 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
1,431 Previous Clinical Trials
2,478,863 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using or plan to use blood thinners.I am over 19 and have a low consciousness level after a cardiac arrest.I had heart monitoring started within 3 days after a cardiac arrest.Your blood doesn't clot normally, or you have low platelet levels.I have had a severe brain injury, bleeding in the brain, or a stroke.My heart has stopped for more than 10 minutes before.Your body temperature is below 35°C.
Research Study Groups:
This trial has the following groups:- Group 1: Neuromonitoring arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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