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Remote Ischemic Conditioning for Traumatic Brain Injury
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your Glasgow Coma Scale (GCS) score is 12 or lower.I had a device placed in my head to monitor pressure before another procedure.You have a serious head injury and are being treated at St. Michael's Hospital within 48 hours of the injury.I can receive treatment within 2 days of my injury.The patient passed away within 24 hours of being admitted.My CT scan shows a brain bleed that explains my level of consciousness.We do not know when the injury occurred.I cannot have specific arm treatments due to past injury, surgery, vascular disease, or radiation.I was taking blood thinners or anti-platelet medications before being hospitalized.I had surgery within 12 hours of arriving at the hospital, not including pressure monitor placement.I have not had a recent serious injury outside my head and neck area that needed hospital care.I am under 18 years old.
- Group 1: Control Arm
- Group 2: RIC Arm
- 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.
Frequently Asked Questions
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."
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."
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."
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