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

Oregon Health and Science University94 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Augmented Blood PressureOTHER

Subjects will have their blood pressure kept in a higher range.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Subject is 18 years of age or older. Exclusion Criteria: 1. Penetrating SCI injury. 2. Isolated cauda equina syndrome or injury at bony level Th9 or below. 3. Pre-existing motor deficit secondary to chronic myelopathy. 4. History of demyelinating disease or central nervous system autoimmune disorder. 5. 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). 6. Acute, evolving or recent (30 days) myocardial infarction. 7. Chronic renal failure requiring dialysis. 8. Suspected or confirmed pregnancy. 9. Severe terminal disease with life expectancy less than 6 months. 10. Severe traumatic brain injury at presentation (GCS ≤8) with confirmation of injury on brain imaging. 11. 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. 12. Non-English or Non-Spanish Speaking. 13. Refusal of consent.

Locations (11)

University of Southern California

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score

Change from baseline in ASIA Upper Extremities Motor Score (UEMS), 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. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.

Time frame: 6 months after spinal cord injury

Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score

Change from baseline in ASIA Lower Extremities Motor Score (LEMS), 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. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.

Time frame: 6 months after spinal cord injury

Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score

Change from baseline in ASIA Sensory Score, 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. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.

Time frame: 6 months after spinal cord injury

Secondary Outcomes

Spinal Cord Independence Measure III Score

Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence.

Time frame: 6 months after spinal cord injury

Pain Scores on the International Spinal Cord Injury Basic Pain Data Set

Data from ClinicalTrials.gov

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