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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after randomization or icu discharge
Awards & highlights
TEMPLE Trial 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.Check my eligibility
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.See study design
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.
TEMPLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a recent spinal cord injury between my neck and upper back with significant loss of motor function.
TEMPLE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.
Secondary outcome measures
Cardiovascular Function
Pain scores on the International Spinal Cord Injury Basic Pain Data Set
Quality of Life
+1 moreOther outcome measures
Number of cardiac complications
Number of respiratory complications
Sequential Multiple Organ Failure score (SOFA)
TEMPLE 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
976 Previous Clinical Trials
7,386,117 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,547 Total Patients Enrolled
Miriam Treggiari, MD, PhD, MPHPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal cord injury is at the lower back or tailbone area.I have a history of a disease that affects the protective covering of nerves or an autoimmune disorder affecting my brain or spinal cord.I am on dialysis for chronic kidney failure.I do not have a condition like Alzheimer's, stroke, or brain tumor that affects my neurological exam.I do not speak English or Spanish.I am 18 years old or older.I have had severe heart failure symptoms in the last 6 months.I have had a heart attack in the last 30 days.My doctor expects I have less than 6 months to live due to my severe illness.I had a severe brain injury confirmed by a scan.I have a recent spinal cord injury between my neck and upper back with significant loss of motor function.I have long-term mobility issues due to spinal cord disease.
Research Study Groups:
This trial has the following groups:- Group 1: Augmented Blood Pressure
- Group 2: Conventional Blood Pressure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have signed up for participation in this study?
"Affirmative. Clinicaltrials.gov offers evidence that this clinical trial, first published on April 10th 2017 is actively recruiting participants. 7 medical sites are needed to enrol 152 patients for the study."
Answered by AI
Are individuals still welcomed to join the current trial?
"As indicated on clinicaltrials.gov, enrollment for this study is still open and has been since April 10th 2017. The information was last updated on May 23rd 2022."
Answered by AI
What is the aggregate number of healthcare establishments conducting this experiment?
"This research initiative is presently running out of 7 trial sites, spread across Charlotte, Winston-Salem and Los Angeles. To minimise the burden on participants, it is advised to choose a centre closest to you in order to reduce travel requirements."
Answered by AI
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