Clinical trial NCT02878850: Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Official title: Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-08-25
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.
timeFrame: 6 months after spinal cord injury
Secondary outcomes:
measure: Spinal Cord Independence Measure III score
timeFrame: 6 months after spinal cord injury
measure: Pain scores on the International Spinal Cord Injury Basic Pain Data Set
timeFrame: 6 months after spinal cord injury
measure: Quality of Life
timeFrame: 6 months after spinal cord injury
measure: Cardiovascular Function
timeFrame: 6 months after spinal cord injury
Other outcomes:
measure: Number of respiratory complications
timeFrame: 7 days after randomization or ICU discharge
measure: Number of cardiac complications
timeFrame: 7 days after randomization or ICU discharge
measure: Sequential Multiple Organ Failure score (SOFA)
timeFrame: 7 days after randomization or ICU discharge
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Charlotte
country: United States
facility: Atrium Health F.H. Sammy Ross Trauma Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Oregon Health and Science University
name: Miriam Treggiari, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weinberg JA, Farber SH, Kalamchi LD, Brigeman ST, Bohl MA, Varda BM, Sioda NA, Radosevich JJ, Chapple KM, Snyder LA. Mean arterial pressure maintenance following spinal cord injury: Does meeting the target matter? J Trauma Acute Care Surg. 2021 Jan 1;90(1):97-106. doi: 10.1097/TA.0000000000002953.