Remote Ischemic Conditioning as a Treatment for Traumatic Brain Injury
Traumatic Brain Injury, Trauma, Nervous System, Reperfusion Injury
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain injury, Remote ischemic conditioning (RIC), Trauma, Biomarkers
Eligibility Criteria
Inclusion Criteria:
- Severe blunt traumatic brain injury presenting to St Michael's Hospital within 8 hours of trauma
- Glasgow Coma Scale (GCS) less than or equal to 8
- Presence on CT Scan of intra-cranial hematoma which adequately explains level of consciousness (epidural, subdural, subarachnoid hematomae)
- Able to undergo intervention within 8 hours of trauma
Exclusion Criteria:
- Age <18 years
- Lack of informed consent or withdrawal of consent, provided by legal substitute decision maker
- Unknown timing of trauma
- Unable to safely undergo ischemic conditioning of the upper extremity due to major trauma, previous surgery, known vascular disease or previous radiation treatment
- Acute significant injury (those injuries which in isolation would require admission to hospital) outside the head and neck region
- Pre-hospital therapeutic anticoagulation or anti-platelet agent use
- Surgical intervention within 12 hours of presentation to hospital, excluding pressure monitor insertion
- Patient death within 24 hours of admission
- Pre-intervention insertion of intra-cranial pressure monitor, as surgical trauma may influence biomarker measurements
Sites / Locations
- St Michaels HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Control Arm
RIC Arm
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.
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.