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
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: Augmented Blood Pressure||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- Spinal Cord Independence Measure III score [ Time Frame: 6 months after spinal cord injury ]Spinal Cord Independence Measure III (Total Score, no units)
- 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)
- Quality of Life [ Time Frame: 6 months after spinal cord injury ]Quality of Life (Life Satisfaction Score; range 0-10)
- Cardiovascular Function [ Time Frame: 6 months after spinal cord injury ]Cardiovascular Function (Event occurrence)
- Number of respiratory complications [ Time Frame: 7 days after randomization or ICU discharge ]Number of respiratory complications (Event frequency)
- Number of cardiac complications [ Time Frame: 7 days after randomization or ICU discharge ]Number of cardiac complications (Event frequency)
- 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Connecticut|
|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|
|Principal Investigator:||Miriam Treggiari, MD, PhD, MPH||Oregon Health and Science University|
|Responsible Party:||Miriam Treggiari, Professor, Oregon Health and Science University|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System