Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Augmented Blood Pressure
Subjects will have their blood pressure kept in a higher range.
  • Other: 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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Jennifer Penn-Touré, B.A., CAPM
913-588-0068
jtoure@kumc.edu

More Details

Status
Recruiting
Sponsor
Oregon Health and Science University

Study Contact

Michael Kampp, BS, CCRP
203-737-5118
michael.kampp@yale.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.