Back to resultsRandomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury (TEMPLE)
Primary Purpose
Spinal Cord Injury
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Blood Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
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.
Sites / Locations
- University of Southern California
- Yale University
- University of Kansas Medical Center
- University of Maryland Medical Center
- Atrium Health F.H. Sammy Ross Trauma Center
- Atrium Health Wake Forest Baptist
- University of Cincinnati Medical Center
- Oregon Health & Science University
- University of Pennsylvania Health System
- Thomas Jefferson University
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Augmented Blood Pressure
Conventional Blood Pressure
Arm Description
Subjects will have their blood pressure kept in a higher range.
Subjects will have their blood pressure kept in a normal range.
Outcomes
Primary Outcome Measures
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.
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
Spinal Cord Independence Measure III score
Spinal Cord Independence Measure III (Total Score, no units)
Pain scores on the International Spinal Cord Injury Basic Pain Data Set
Pain scores on the International Spinal Cord Injury Basic Pain Data Set (Pain Interference Score; range 0-10)
Quality of Life
Quality of Life (Life Satisfaction Score; range 0-10)
Cardiovascular Function
Cardiovascular Function (Event occurrence)
Full Information
NCT ID
NCT02878850
First Posted
August 3, 2016
Last Updated
March 13, 2023
Sponsor
Oregon Health and Science University
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT02878850
Brief Title
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Acronym
TEMPLE
Official Title
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Augmented Blood Pressure
Arm Type
Experimental
Arm Description
Subjects will have their blood pressure kept in a higher range.
Arm Title
Conventional Blood Pressure
Arm Type
No Intervention
Arm Description
Subjects will have their blood pressure kept in a normal range.
Intervention Type
Other
Intervention Name(s)
Augmented Blood Pressure
Intervention Description
Subjects will have their blood pressure kept in a higher range.
Primary Outcome Measure Information:
Title
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.
Description
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.
Time Frame
6 months after spinal cord injury
Secondary Outcome Measure Information:
Title
Spinal Cord Independence Measure III score
Description
Spinal Cord Independence Measure III (Total Score, no units)
Time Frame
6 months after spinal cord injury
Title
Pain scores on the International Spinal Cord Injury Basic Pain Data Set
Description
Pain scores on the International Spinal Cord Injury Basic Pain Data Set (Pain Interference Score; range 0-10)
Time Frame
6 months after spinal cord injury
Title
Quality of Life
Description
Quality of Life (Life Satisfaction Score; range 0-10)
Time Frame
6 months after spinal cord injury
Title
Cardiovascular Function
Description
Cardiovascular Function (Event occurrence)
Time Frame
6 months after spinal cord injury
Other Pre-specified Outcome Measures:
Title
Number of respiratory complications
Description
Number of respiratory complications (Event frequency)
Time Frame
7 days after randomization or ICU discharge
Title
Number of cardiac complications
Description
Number of cardiac complications (Event frequency)
Time Frame
7 days after randomization or ICU discharge
Title
Sequential Multiple Organ Failure score (SOFA)
Description
Sequential Multiple Organ Failure score (SOFA) (Total Score, no units)
Time Frame
7 days after randomization or ICU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Treggiari, MD, PhD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Atrium Health F.H. Sammy Ross Trauma Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33003016
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.
Results Reference
derived
Learn more about this trial
Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
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