Skip to main content
OpenTrials
Completed

NCT Number: NCT02878850

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Subject is 18 years of age or older.

Exclusion criteria

  • 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.

Treatment and study plan

Augmented Blood Pressure

Other

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

Primary outcomes

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

    Time frame: 6 months after spinal cord injury

    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.

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

    Time frame: 6 months after spinal cord injury

    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.

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

    Time frame: 6 months after spinal cord injury

    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.

Secondary outcomes

  1. Spinal Cord Independence Measure III Score

    Time frame: 6 months after spinal cord injury

    Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence.

  2. Pain Scores on the International Spinal Cord Injury Basic Pain Data Set

    Time frame: 6 months after spinal cord injury

    Pain Interference with daily activity on the International Spinal Cord Injury Basic Pain Data Set. Pain Interference Score ranges from 0 to 10, with higher scores indicating higher pain levels.

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

    Time frame: 6 months after spinal cord injury

    The ISCIQoL Basic Data Set is a 3-item self-report tool of quality of life across three domains: 1. Satisfaction with life as a whole; 2. Satisfaction with physical health; 3. Satisfaction with psychological health. Each domain scores from 0 to 10, and the total score range (sum of the 3 domains) ranges from 0 to 30. Higher scores indicate better perceived quality of life.

Other outcomes

  1. Incidence of Respiratory Complications

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

    Incidence of respiratory complications

  2. Cardiovascular Function

    Time frame: 6 months after spinal cord injury

    Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition.

  3. Sequential Multiple Organ Assessment (SOFA) Score

    Time frame: 7 days after randomization

    Modified Sequential Multiple Organ Assessment (SOFA) score on Day 7 after randomization. The modified SOFA score does not include the points contributed by the Cardiovascular system. The modified SOFA score ranges from 0 to 20, with higher scores indicating greater organ dysfunction and higher mortality risk.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: TEMPLE

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2016
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.