Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Purpose
The purpose of this study is to learn more about how participants heal from acute spinal cord injury.
Condition
- Spinal Cord Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. 2. Subject is 18 years of age or older.
Exclusion Criteria
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Augmented Blood Pressure |
Subjects will have their blood pressure kept in a higher range. |
|
|
No Intervention Conventional Blood Pressure |
Subjects will have their blood pressure kept in a normal range. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Oregon Health and Science University
Study Contact
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.