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

Not Applicable

Active, not recruiting

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Augmented Blood Pressure	Augmented Blood Pressure	Subjects will have their blood pressure kept in a higher range.

Primary Outcome Measures

Name	Time	Method
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.	6 months after spinal cord injury	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.

Secondary Outcome Measures

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

Locations (11): Atrium Health F.H. Sammy Ross Trauma Center
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Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist
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Winston-Salem, North Carolina, United States
Oregon Health & Science University
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Portland, Oregon, United States
Yale University
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New Haven, Connecticut, United States
University of Southern California
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Los Angeles, California, United States
University of Maryland Medical Center
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Baltimore, Maryland, United States
University of Cincinnati Medical Center
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Cincinnati, Ohio, United States
University of Pennsylvania Health System
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Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
University of Kansas Medical Center
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Kansas City, Kansas, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States