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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
Invasive monitoring implemented within 72 hours of cardiac arrest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post arrest
Awards & highlights

DIFFUSION Trial 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.

DIFFUSION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 19 and have a low consciousness level after a cardiac arrest.
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I had heart monitoring started within 3 days after a cardiac arrest.
Select...
My heart has stopped for more than 10 minutes before.

DIFFUSION Trial 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

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 more

DIFFUSION 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
1,412 Previous Clinical Trials
2,466,545 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any participants needed for this clinical trial currently?

"Clinicaltrials.gov has verified that this medical study is actively enrolling patients. The trial was initially posted on October 27th of 2020 and received its most recent update on May 23rd 2022."

Answered by AI

Is there a limit to the amount of participants in this clinical trial?

"Correct. Information available on clinicaltrials.gov confirms that this medical investigation, which was initiated in October 2020, is currently recruiting participants. 40 individuals need to be enrolled from a single establishment."

Answered by AI
~5 spots leftby Oct 2024