Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this study is to learn more about how participants heal from acute spinal cord injury.

Detailed Description
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In this study, the investigators will learn about the effect of targeted blood pressure management (TPM) on participants healing from acute spinal cord injury. The investigators want to learn: The effect of two types of TPM on long term motor and sensory outcomes. The effect of two types of TPM on long-term pain and functional independence outcomes. How safe TPM is for participants.

Official Title
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Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Other: Augmented Blood Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute traumatic spinal cord injury (SCI) involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C. Subject is 18 years of age or older. Exclusion Criteria: Penetrating SCI injury. Isolated cauda equina syndrome or injury at bony level Th9 or below. Pre-existing motor deficit secondary to chronic myelopathy. History of demyelinating disease or central nervous system autoimmune disorder. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D). Acute, evolving or recent (30 days) myocardial infarction. Chronic renal failure requiring dialysis. Suspected or confirmed pregnancy. Severe terminal disease with life expectancy less than 6 months. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging. A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation. Non-English or Non-Spanish Speaking. Refusal of consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Blood Pressure<br>Subjects will have their blood pressure kept in a higher range. | Other: Augmented Blood Pressure<br>* Subjects will have their blood pressure kept in a higher range.<br>|
| No Intervention: Conventional Blood Pressure<br>Subjects will have their blood pressure kept in a normal range. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores. | Change from baseline in long-term motor and sensory scores, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. | 6 months after spinal cord injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Cord Independence Measure III score | Spinal Cord Independence Measure III (Total Score, no units) | 6 months after spinal cord injury | 
| Pain scores on the International Spinal Cord Injury Basic Pain Data Set | Pain scores on the International Spinal Cord Injury Basic Pain Data Set (Pain Interference Score; range 0-10) | 6 months after spinal cord injury | 
| Quality of Life | Quality of Life (Life Satisfaction Score; range 0-10) | 6 months after spinal cord injury | 
| Cardiovascular Function | Cardiovascular Function (Event occurrence) | 6 months after spinal cord injury |