CompletedNot Applicable

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

United States94 participantsStarted 2017-05-22

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

Timeframe: 6 months after spinal cord injury

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

Timeframe: 6 months after spinal cord injury

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

Timeframe: 6 months after spinal cord injury

NCT IDNCT02878850

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-26

Results submitted2025-08-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

What they're measuring

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

Timeframe: 6 months after spinal cord injury

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

Timeframe: 6 months after spinal cord injury

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

Timeframe: 6 months after spinal cord injury