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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days after randomization or icu discharge

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)

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.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

994 Previous Clinical Trials

7,386,796 Total Patients Enrolled

United States Department of DefenseFED

891 Previous Clinical Trials

332,326 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 Sep 2025

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