N/A
N=92
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02878850 ↗Enrolled (actual)
92
Serious AEs
27.2%
Results posted
Nov 2025
Primary outcome: Primary: Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score — 15.58; 12.63 Scores on a scale — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Augmented Blood Pressure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score |
15.58; 12.63 | 0.55 |
| PRIMARY Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score |
10.79; 16.16 | 0.35 |
| PRIMARY Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score |
6.26; 41.63 | 0.04 sig |
| SECONDARY Spinal Cord Independence Measure III Score |
27.48; 28.11 | 0.92 |
| SECONDARY Pain Scores on the International Spinal Cord Injury Basic Pain Data Set |
5.21; 4.86 | 0.75 |
| SECONDARY International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set |
19.94; 18.00 | 0.40 |
Summary
The purpose of this study is to learn more about how participants heal from acute spinal cord injury.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02878850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.