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Augmented Blood Pressure Management for Spinal Cord Injury (TEMPLE Trial)

N/A
Waitlist Available
Led By Miriam Treggiari, MD, PhD, MPH
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is 18 years of age or older
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
Must not have
Isolated cauda equina syndrome or injury at bony level Th9 or below
History of demyelinating disease or central nervous system autoimmune disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after randomization or icu discharge
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how people heal from spinal cord injuries.

Who is the study for?
This trial is for adults over 18 with a recent traumatic spinal cord injury between the neck and upper back (C0-T8) resulting in significant loss of motor function (ASIA level A, B, or C). It's not for those with penetrating injuries, lower back injuries (below T8), chronic myelopathy, demyelinating diseases, severe heart failure or recent heart attack, kidney failure requiring dialysis, pregnancy, terminal illness with less than 6 months to live, non-English/Spanish speakers who refuse consent or can't undergo accurate neurological exams due to certain conditions.
What is being tested?
The study is testing 'Augmented Blood Pressure' management as an early intervention after acute spinal cord injury. The goal is to understand how this approach affects healing and recovery from such injuries.
What are the potential side effects?
While specific side effects are not listed here for Augmented Blood Pressure management in acute spinal cord injury patients; generally speaking interventions like these could potentially lead to issues related to blood pressure changes such as dizziness or increased risk of stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a recent spinal cord injury between my neck and upper back with significant loss of motor function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My spinal cord injury is at the lower back or tailbone area.
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I have a history of a disease that affects the protective covering of nerves or an autoimmune disorder affecting my brain or spinal cord.
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I am on dialysis for chronic kidney failure.
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I do not have a condition like Alzheimer's, stroke, or brain tumor that affects my neurological exam.
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I do not speak English or Spanish.
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I have had severe heart failure symptoms in the last 6 months.
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I have had a heart attack in the last 30 days.
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My doctor expects I have less than 6 months to live due to my severe illness.
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I had a severe brain injury confirmed by a scan.
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I have long-term mobility issues due to spinal cord disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after randomization or icu discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after randomization or icu discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.
Secondary study objectives
Cardiovascular Function
Pain scores on the International Spinal Cord Injury Basic Pain Data Set
Quality of Life
+1 more
Other study objectives
Number of cardiac complications
Number of respiratory complications
Sequential Multiple Organ Failure score (SOFA)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Augmented Blood PressureExperimental Treatment1 Intervention
Subjects will have their blood pressure kept in a higher range.
Group II: Conventional Blood PressureActive Control1 Intervention
Subjects will have their blood pressure kept in a normal range.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,960 Total Patients Enrolled
United States Department of DefenseFED
913 Previous Clinical Trials
334,154 Total Patients Enrolled
Miriam Treggiari, MD, PhD, MPHPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University

Media Library

Augmented Blood Pressure (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02878850 — N/A
Spinal Cord Injury Research Study Groups: Augmented Blood Pressure, Conventional Blood Pressure
Spinal Cord Injury Clinical Trial 2023: Augmented Blood Pressure Highlights & Side Effects. Trial Name: NCT02878850 — N/A
Augmented Blood Pressure (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02878850 — N/A
~18 spots leftby Dec 2025
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