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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878850
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : March 15, 2023
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Miriam Treggiari, Oregon Health and Science University

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: Augmented Blood Pressure Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores. [ Time Frame: 6 months after spinal cord injury ]
    Change from baseline in long-term motor and sensory scores, 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.


Secondary Outcome Measures :
  1. Spinal Cord Independence Measure III score [ Time Frame: 6 months after spinal cord injury ]
    Spinal Cord Independence Measure III (Total Score, no units)

  2. Pain scores on the International Spinal Cord Injury Basic Pain Data Set [ Time Frame: 6 months after spinal cord injury ]
    Pain scores on the International Spinal Cord Injury Basic Pain Data Set (Pain Interference Score; range 0-10)

  3. Quality of Life [ Time Frame: 6 months after spinal cord injury ]
    Quality of Life (Life Satisfaction Score; range 0-10)

  4. Cardiovascular Function [ Time Frame: 6 months after spinal cord injury ]
    Cardiovascular Function (Event occurrence)


Other Outcome Measures:
  1. Number of respiratory complications [ Time Frame: 7 days after randomization or ICU discharge ]
    Number of respiratory complications (Event frequency)

  2. Number of cardiac complications [ Time Frame: 7 days after randomization or ICU discharge ]
    Number of cardiac complications (Event frequency)

  3. Sequential Multiple Organ Failure score (SOFA) [ Time Frame: 7 days after randomization or ICU discharge ]
    Sequential Multiple Organ Failure score (SOFA) (Total Score, no units)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878850


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, North Carolina
Atrium Health F.H. Sammy Ross Trauma Center
Charlotte, North Carolina, United States, 28203
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Oregon Health and Science University
United States Department of Defense
Investigators
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Principal Investigator: Miriam Treggiari, MD, PhD, MPH Oregon Health and Science University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Miriam Treggiari, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02878850    
Other Study ID Numbers: TEMPLE - 001
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System