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

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ClinicalTrials.gov Identifier: NCT02878850
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Spinal Cord Injury Other: Augmented Blood Pressure

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

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 : January 10, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Augmented Blood Pressure
Subjects will have their blood pressure kept in a higher range.
Other: Augmented Blood Pressure
No Intervention: Conventional Blood Pressure
Subjects will have their blood pressure kept in a normal range.


Outcome Measures

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute traumatic 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 or B.
  2. Subject or their legal representative has signed the informed consent.
  3. Subject is 18 years of age or older.

Exclusion Criteria:

  1. Penetrating SCI injury.
  2. Isolated cauda equine syndrome or injury at bony level Th9 or below.
  3. Central cord syndrome, as determined by the primary admitting team.
  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).
  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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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


Contacts
Contact: Michael Kampp, BS, CCRP 503-494-5224 kamppm@ohsu.edu
Contact: Laura Sissons-Ross, AS 503-494-9545 sissonsr@ohsu.edu

Locations
United States, Maryland
University of Maryland Medical Center (UM) Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark Scarboro, MD       mscarboro@stapa.umm.edu   
Principal Investigator: Jay Menaker, MD         
United States, Ohio
University of Cincinnati Medical Center (UC) Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Dina Gomma    513-558-6305    dina.gomma@uc.edu   
Principal Investigator: Jay Johannigman, MD         
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Kampp, CCRP    503-494-5224    kamppm@ohsu.edu   
Principal Investigator: Miriam Treggiari, MD         
United States, Pennsylvania
University of Pennsylvania Health System (UP) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joy Steele    215-662-9423    joy.steele@uphs.upenn.edu   
Principal Investigator: Neils Martin, MD         
United States, Washington
Harborview Medical Center (UW) Recruiting
Seattle, Washington, United States, 98104
Contact: Amy Anderson, BSN, RN    206-744-9364    amya9@uw.edu   
Principal Investigator: Randall Chesnut, MD         
Sponsors and Collaborators
Oregon Health and Science University
United States Department of Defense
Investigators
Principal Investigator: Miriam Treggiari, MD, PhD, MPH Oregon Health and Science University
More Information

Responsible Party: Miriam Treggiari, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02878850     History of Changes
Other Study ID Numbers: TEMPLE - 001
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System