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



Status:Recruiting
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 10, 2017
End Date:December 2020
Contact:Michael Kampp, BS, CCRP
Email:kamppm@ohsu.edu
Phone:503-494-5224

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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.

Inclusion Criteria:

1. Acute traumatic 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. Central cord syndrome, as determined by the primary admitting team.

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.
We found this trial at
5
sites
3230 Eden Avenue
Cincinnati, Ohio 45267
Principal Investigator: Jay Johannigman, MD
Phone: 513-558-6305
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22 South Greene Street
Baltimore, Maryland 21201
Principal Investigator: Jay Menaker, MD
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
Principal Investigator: Neils Martin, MD
Phone: 215-662-9423
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Portland, Oregon 97201
Principal Investigator: Miriam Treggiari, MD
Phone: 503-494-5224
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325 9th Avenue
Seattle, Washington 98104
Principal Investigator: Randall Chesnut, MD
Phone: 206-744-9364
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