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

NCT02878850 | Completed Results DMC

• 2 other identifiers: TEMPLE - 001CDMRP-SC150250
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score

  Change from baseline in ASIA Upper Extremities Motor Score (UEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.

  6 months after spinal cord injury

• Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score

  Change from baseline in ASIA Lower Extremities Motor Score (LEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.

  6 months after spinal cord injury

• Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score

  Change from baseline in ASIA Sensory Score, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.

  6 months after spinal cord injury

Secondary Outcomes (3)

• Spinal Cord Independence Measure III Score

  6 months after spinal cord injury

• Pain Scores on the International Spinal Cord Injury Basic Pain Data Set

  6 months after spinal cord injury

• International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set

  6 months after spinal cord injury

Other Outcomes (3)

• Incidence of Respiratory Complications

  7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days

• Cardiovascular Function

  6 months after spinal cord injury

• Sequential Multiple Organ Assessment (SOFA) Score

  7 days after randomization

Study Arms (2)

Augmented Blood Pressure

EXPERIMENTAL

Subjects will have their blood pressure kept in a higher range.

Other: Augmented Blood Pressure

Conventional Blood Pressure

NO INTERVENTION

Subjects will have their blood pressure kept in a normal range.

Interventions

Augmented Blood Pressure OTHER

Subjects will have their blood pressure kept in a higher range.

Augmented Blood Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• United States Department of Defense: collaborator

Study Sites (11)

University of Southern California

Los Angeles, California, 90033, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Atrium Health F.H. Sammy Ross Trauma Center

Charlotte, North Carolina, 28203, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Sajdeya R, Yanez ND, Kampp M, Goodman MD, Zonies D, Togioka B, Nunn A, Winfield RD, Martin ND, Kohli A, Huynh TT, Okonkwo DO, Poblete RA, Gilmore EJ, Chesnut RM, Bunnell AE, Ohnuma T, Hashemaghaie M, Treggiari MM. Early Blood Pressure Targets in Acute Spinal Cord Injury: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2525364. doi: 10.1001/jamanetworkopen.2025.25364.

  PMID: 40965887 DERIVED

• 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.

  PMID: 33003016 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Miriam Treggiari
• Organization: Duke University

miriam.treggiari@duke.edu

9196819933

Study Officials

• Miriam Treggiari, MD, PhD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 25, 2016
• Study Start: May 22, 2017
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: January 21, 2026
• Results First Posted: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)