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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health F.H. Sammy Ross Trauma Center
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score	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.	6 months after spinal cord injury
Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score	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.	6 months after spinal cord injury
Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score	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.	6 months after spinal cord injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Cord Independence Measure III Score	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.	6 months after spinal cord injury
Pain Scores on the International Spinal Cord Injury Basic Pain Data Set	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.	6 months after spinal cord injury
International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set	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.	6 months after spinal cord injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Respiratory Complications	Incidence of respiratory complications	7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days
Cardiovascular Function	Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition.	6 months after spinal cord injury
Sequential Multiple Organ Assessment (SOFA) Score	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.	7 days after randomization

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Miriam Treggiari, MD, PhD, MPH, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.
• Sajdeya R, Yanez ND, Kampp M, Goodman MD, Zonies D, Togioka B, Nunn A, Winfield RD, Martin ND, Kohli A, Huynh TT, Okonkwo DO, Poblete RA, Gilmore EJ, Chesnut RM, Bunnell AE, Ohnuma T, Hashemaghaie M, Treggiari MM. Early Blood Pressure Targets in Acute Spinal Cord Injury: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2525364. doi: 10.1001/jamanetworkopen.2025.25364.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 20, 2016
• First Posted (Estimated): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: TEMPLE - 001; CDMRP-SC150250 (Other Grant/Funding Number: United States Department of Defense, CDMRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No