Traumatic Brain Injury Clinical Trial
Official title:
Remote Ischemic Conditioning as a Treatment for Traumatic Brain Injury: a Prospective Randomized Controlled Trial.
NCT number | NCT03176823 |
Other study ID # | RIC in TBI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2019 |
Est. completion date | March 3, 2024 |
Verified date | March 2024 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The prevention of secondary brain injury is a primary goal in treating patients with severe traumatic brain injury (TBI). Secondary brain injury results from tissue ischemia induced by increased vascular resistance in the at-risk brain tissue due to compression by traumatic hematomas, and development of cytotoxic and vasogenic tissue edema. While traumatic hematomas may be managed surgically, cytotoxic and vasogenic edema with resulting perfusion impairment perpetuates brain ischemia and injury. Animal models suggest that remote ischemic conditioning (RIC) can reverse these effects and improve perfusion. Based on these findings it is hypothesized that RIC will exert beneficial effects on TBI in man, thereby representing a new therapeutic strategy for severe TBI. Patients presenting to our institution suffering from severe TBI will be considered for enrollment. Eligible patients will have sustained a blunt, severe TBI (defined by Glasgow Coma Scale <8) with associated intra-cranial hematoma(s) not requiring immediate surgical decompression, with admission to an intensive care unit and insertion of an intra-cranial pressure monitor. Patients will be randomized to RIC versus sham-RIC intervention cohorts. RIC interventions will be performed using an automated device on the upper extremity delivering 20 cumulative minutes of limb ischemia in a single treatment session. The planned enrollment is a cohort of 40 patients. Outcomes of this study will include multiple domains. Our primary outcome will include serial assessments of validated serum biomarkers of neuronal injury and systemic inflammation. Secondary outcomes will include descriptions of the clinical course of each patient, radiologic assessment of brain perfusion, and neurocognitive and psychological assessment post-discharge. If clinical outcomes are improved using RIC, this study would support RIC as a novel treatment for TBI. Its advantages include safety and simplicity and, requiring no specialized equipment, its ability to be used in any environment including pre-hospital settings or in austere theatres. The investigators anticipate that TBI patients treated with RIC will have improved clinical, biochemical, and neuropsychological outcomes compared to standard treatment protocols.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 3, 2024 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Severe blunt traumatic brain injury presenting to St Michael's Hospital within 48 hours of trauma - Glasgow Coma Scale (GCS) less than or equal to 12 - Presence on CT Scan of intra-cranial hematoma which adequately explains level of consciousness (epidural, subdural, subarachnoid hematomae) - Able to undergo intervention within 48 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St Michaels Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | Defence Research and Development Canada |
Canada,
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* Note: There are 44 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neuron Specific Enolase (NSE) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | S100A12 - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Calcium Binding Protein Beta (S100B) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Glial Fibrillary Acidic Protein (GFAP) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Monocyte Chemoattractant Protein (MCP1) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Epinephrine - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Norepinephrine - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Interleukin 10 (IL10) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Interleukin 1 Beta (IL1B) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Tumor Necrosis Factor Alpha (TNF Alpha) - biomarker | Plasma concentration measured by measured by enzyme-linked immunosorbent ELISA and multiplex platform at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | International Normalized Ratio (INR) - standard lab test. | Standard coagulation parameter, to be measured at all time points specified below. | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Prothrombin Time (PTT) - standard lab test. | Standard coagulation parameter, to be measured at all time points specified below | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Primary | Rotational Thromboelastometry (ROTEM), standard lab test. | ROTEM coagulation assessment using the commercial ROTEM device traditionally used for the assessment of trauma-induced coagulopathy, to be measured at all time points specified below | Admission (0 hours), 6 hours, 24 hours, 48 hours, and 72 hours | |
Secondary | Cerebral vascular perfusion, acute | Patients will undergo Arterial Spin Loading Functional Magnetic Resonance Imaging (fMRI) at 72 hours post-RIC to quantify blood flow to the acutely ischemic brain parenchyma. | 24 hours | |
Secondary | Intracranial Pressure (ICP) measurement, first 24 hours | The number of episodes of ICP >20 mmHg, measured in 15 minute increments, over the first 24 hours. | 24 hours | |
Secondary | Intracranial Pressure (ICP) measurement, 24-96 hours | The number of episodes of ICP >20 mmHg, measured in 15 minute increments, over 24-96 hours. | 24 hours, 96 hours | |
Secondary | Escalation along an established care algorithm | Patient care interventions will be plotted against the Tier 1, Tier 2, and Tier 3 categories of interventions described by the American College of Surgeons Trauma Quality Improvement Program (ACS TQIP) guidelines for the management of traumatic intracranial hypertension. | 12 months | |
Secondary | Mortality beyond 12 hours post-admission | Patient deaths occurring in the first 12 hours will result in patient-exclusion as it is unlikely that these patients would have had different outcomes regardless of treatment strategies. | 12 months | |
Secondary | Incidence of surgical decompression beyond 12 hours post-admission | Patient progression to need for definitive surgery occurring in the first 12 hours will result in patient-exclusion as it is unlikely that these patients would have had different outcomes regardless of treatment strategies. | 12 months | |
Secondary | Hospital length of stay, number of days | Number of continuous calendar days or partial calendar days admitted to an acute-care hospital. | 12 months | |
Secondary | Intensive Care Unit length of stay, number of days | Number of continuous calendar days or partial calendar days admitted to an intensive-care unit. | 2 months | |
Secondary | Total duration of mechanical ventilation, number of days | Number of calendar days or partial calendar days including treatment with invasive ventilation. | 2 months | |
Secondary | Destination of discharge | Home (functionally independent), rehabilitation facility, or chronic care facility | 12 months | |
Secondary | Glasgow Outcomes Scale, Extended (GOSE) - neurocognitive test | The GOSE scale assessing neurocognitive function will be assessed on hospital, discharge, at three months post-discharge, and at 6 and 12 months post-discharge. | discharge, 3 months, 6 months, and 12 months | |
Secondary | Disability Rating Scale (DRS) - neurocognitive function rating | The DRS scale assessing neurocognitive function will be assessed on hospital discharge, at three months post-discharge, and at 6 and 12 months post-discharge. | discharge, 3 months, 6 months, and 12 months | |
Secondary | Patient Health Questionnaire 9th edition (PHQ-9) - neurological - self assessment | The PHQ-9 screen for mental health disorders will be assessed on hospital discharge, at three months post-discharge, and at 6 and 12 months post-discharge. | discharge, 3, 6, and 12 months | |
Secondary | Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (PCL-5) - neurological - self assessment | The PCL-5 screen for Post-Traumatic Stress Disorder will be assessed on hospital discharge, at three months post-discharge, and at 6 and 12 months post-discharge. | discharge, 3 months, 6 months, and 12 months |
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