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Remote Ischemic Conditioning for Traumatic Brain Injury

N/A
Waitlist Available
Led By Ori D Rotstein, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to undergo intervention within 48 hours of trauma
Presence on CT Scan of intra-cranial hematoma which adequately explains level of consciousness (epidural, subdural, subarachnoid hematomae)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up discharge, 3, 6, and 12 months
Awards & highlights

Study Summary

This trial will test a new treatment strategy (RIC) for severe TBI to improve patient outcomes with the potential to be used in any environment.

Who is the study for?
This trial is for adults with severe blunt traumatic brain injury (TBI) who arrive at St Michael's Hospital within 48 hours of the incident. They must have a Glasgow Coma Scale score of 12 or less and a CT scan showing intra-cranial hematoma. Candidates should not have significant injuries outside the head, be on certain blood thinners, need major surgery within 12 hours (except pressure monitor insertion), or die within 24 hours of admission.Check my eligibility
What is being tested?
The study tests if Remote Ischemic Conditioning (RIC) using an automated device can improve outcomes in TBI patients by increasing brain perfusion. Patients are randomly assigned to receive RIC or a sham procedure alongside standard care. The treatment involves creating brief periods of limb ischemia and will include assessments like serum biomarkers, radiologic exams, and neurocognitive evaluations post-discharge.See study design
What are the potential side effects?
While specific side effects are not listed for RIC in this summary, generally it may cause discomfort or bruising where the device is applied on the upper extremity. Since it's non-invasive, risks tend to be low compared to drug treatments but could include temporary changes in circulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can receive treatment within 2 days of my injury.
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My CT scan shows a brain bleed that explains my level of consciousness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~discharge, 3, 6, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and discharge, 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Calcium Binding Protein Beta (S100B) - biomarker
Epinephrine - biomarker
Glial Fibrillary Acidic Protein (GFAP) - biomarker
+10 more
Secondary outcome measures
Cerebral vascular perfusion, acute
Destination of discharge
Disability Rating Scale (DRS) - neurocognitive function rating
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RIC ArmExperimental Treatment2 Interventions
The RIC treatment will be applied with a purpose-built commercial RIC device which will aid in standardizing dose and delivery. Therapeutic RIC will be provided by the CellAegis Technologies autoRIC device on an upper extremity. As with the control cohort, this cohort will undergo complete extremity draping.
Group II: Control ArmPlacebo Group1 Intervention
Control-arm patients will be treated with standard "Best Practice" management of traumatic brain injury, with the addition of sham-RIC. The sham intervention will use a purpose-built device which will visually and audibly mimic a functional RIC device, with the key distinction being non-inflation of the arm cuff with resultant non-occlusion and no induced ischemia. To mask patient enrollment, all patients in both study arms will have the arm and RIC device draped in an opaque sheet so that the extremity distal to the RIC device are not visible to medical staff during the period of intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CellAegis Technologies autoRIC device
2019
N/A
~50

Find a Location

Who is running the clinical trial?

Dr. Markus ZiesmannUNKNOWN
Dr. Shawn RhindUNKNOWN
Dr. Sandro RizoliUNKNOWN

Media Library

Best Practice Management of Traumatic Brain Injury (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03176823 — N/A
Traumatic Brain Injury Research Study Groups: Control Arm, RIC Arm
Traumatic Brain Injury Clinical Trial 2023: Best Practice Management of Traumatic Brain Injury Highlights & Side Effects. Trial Name: NCT03176823 — N/A
Best Practice Management of Traumatic Brain Injury (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03176823 — N/A

Frequently Asked Questions

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

How many participants will be recruited into this research study?

"Absolutely. The information hosted on clinicaltrials.gov affirms that this study, initially posted in May 2019, is still actively recruiting participants. 40 patients are expected to be enrolled from 1 medical centre."

Answered by AI

Are medical facilities still enrolling participants for this research experiment?

"Indeed, information available on clinicaltrials.gov shows that this examination is signing up participants. The original posting for the trial occurred on May 3rd 2019 and was most recently modified on August 2nd 2023."

Answered by AI

What is the main goal of this research endeavor?

"This medical trial is primarily designed to measure the S100A12 biomarker over a 72-hour period. Secondary objectives include assessing neurocognitive function using the Disability Rating Scale (DRS) at hospital discharge, three months post-discharge, six and twelve months post-discharge; self assessment of mental health disorders via Patient Health Questionnaire 9th edition (PHQ-9) at similar time points; and Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (PCL-5), again across these same intervals."

Answered by AI
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~8 spots leftby Mar 2025