Spinal Cord InjuryTEMPLENCT02878850

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

A study testing Augmented Blood Pressure in people with Spinal Cord Injury, run by Oregon Health and Science University at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injury
What is being tested?: Augmented Blood Pressure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 11 sitesUnited States
Study dates: 22 May 2017to 26 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Spinal Cord Injury
Being tested: Augmented Blood Pressure
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Augmented Blood PressureOther
Subjects will have their blood pressure kept in a higher range.

Study groups in NCT02878850
Study group	Role	What they receive
Augmented Blood Pressure	Experimental	Subjects will have their blood pressure kept in a higher range. Receives: Other: Augmented Blood Pressure
Conventional Blood Pressure	No intervention	Subjects will have their blood pressure kept in a normal range.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 6 months after spinal cord injury

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: 6 months after spinal cord injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201726 Jul 2023

First posted25 Aug 2016 (estimated)
Study start22 May 2017
Primary completion26 Jul 2023
Study completion26 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02878850
Sponsor's protocol ID: TEMPLE - 001
Other IDs: CDMRP-SC150250
Acronym: TEMPLE
Status last verified: Oct 2025
First submitted: 3 Aug 2016
Last updated: 21 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40965887
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.
PubMed 33003016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury
ClinicalTrials.gov ID: NCT02878850
Acronym / sponsor ID: TEMPLE / TEMPLE - 001
Conditions: Spinal Cord Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 22 May 2017 (actual)
Primary completion: 26 Jul 2023 (actual)
Study completion: 26 Jul 2023 (actual)
First posted: 25 Aug 2016 (estimated)
Results: Posted 24 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Augmented Blood Pressure	Experimental	Other: Augmented Blood PressureSubjects will have their blood pressure kept in a higher range.
Conventional Blood Pressure	No intervention	–Subjects will have their blood pressure kept in a normal range.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (13 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Augmented Blood PressureSubjects will have their blood pressure kept in a higher range.	Other	Augmented Blood Pressure

Primary outcome

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

3 secondary outcomes

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

Results and safety

Results posted to the registry on 24 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Augmented Blood Pressure	46	30
Conventional Blood Pressure	46	35

Primary outcome: Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score

Time frame: 6 months after spinal cord injury. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Augmented Blood Pressure n = 19	Conventional Blood Pressure n = 19
Value	15.58 (16.23)	12.63 (13.42)

Augmented Blood Pressure vs Conventional Blood Pressure: Mean Difference (Final Values): 2.95 (95% CI -6.85 to 12.75), p = 0.55, t-test, 2 sided

Population analysed: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up

Primary outcome: Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score

Time frame: 6 months after spinal cord injury. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Augmented Blood Pressure n = 19	Conventional Blood Pressure n = 19
Value	10.79 (16.66)	16.16 (18.16)

Augmented Blood Pressure vs Conventional Blood Pressure: Mean Difference (Final Values): -5.73 (95% CI -16.84 to 6.10), p = 0.35, t-test, 2 sided

Primary outcome: Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score

Time frame: 6 months after spinal cord injury. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Augmented Blood Pressure n = 19	Conventional Blood Pressure n = 19
Value	6.26 (41.32)	41.63 (58.97)

Augmented Blood Pressure vs Conventional Blood Pressure: Mean Difference (Final Values): -35.37 (95% CI -68.87 to -1.87), p = 0.04, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment up to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Augmented Blood Pressure	12 of 46 (26.1%)	0 of 46 (0%)	8 of 46
Conventional Blood Pressure	13 of 46 (28.3%)	0 of 46 (0%)	7 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40965887Sajdeya 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.
Derived from this study: PubMed 33003016Weinberg 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miriam Treggiari, MD, PhD, MPH principal investigator

Oregon Health and Science University

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Blood Pressure in people with Spinal Cord Injury, run by Oregon Health and Science University at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score (time frame: 6 months after spinal cord injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02878850, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.