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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.

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.

Select...

My heart has stopped for more than 10 minutes before.

DIFFUSION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post arrest

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,467,078 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

Recent research and studies

clinicaltrials.govStudy

Delineating Between Pathophysiologic Phenotypes of Hypoxic Ischemic Brain Injury After Cardiac Arrest

Myp Sekhon 2020. "Delineating Between Pathophysiologic Phenotypes of Hypoxic Ischemic Brain Injury After Cardiac Arrest". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05390060.

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