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Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

This study is looking at different ways to manage blood pressure in people who have recently experienced a traumatic spinal cord injury (SCI). Researchers want to see if keeping your blood pressure at certain levels (mean arterial blood pressure, or MAP, goals of ≥65 mmHg or 85-90 mmHg, or spinal cord perfusion pressure, or SCPP, goal of ≥65 mmHg) in the first five days after injury can improve how well you recover. They will measure your motor skills and ability to do daily activities six weeks after your injury to see which approach works best. You may be able to join if you are 18 or older and have a traumatic spinal cord injury, but not if your injury was from a penetrating wound, you have a pre-existing neurological condition, or a severe traumatic brain injury. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 228 participants to compare different blood pressure management strategies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your recovery will be assessed at six weeks following your injury.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06451133

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

Recruiting
NAAges 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~228 participants
Updated 2024-12-11 on ClinicalTrials.gov
What's tested:Mean arterial blood pressure (MAP) goal of ≥65 mmHgMean arterial blood pressure (MAP) goal of 85-90 mmHgSpinal cord perfusion pressure (SCPP) goal of ≥65 mmHg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The severity of a spinal cord injury (SCI) as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score
Measured over 6 weeks following injury
+1 more outcome measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • David Meyer, MD, MS, FACS · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

David Meyer, MD, MS, FACS
[email protected]
(713) 500-7244
Email the study team

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Eligibility criteria

Inclusion

Traumatic spinal cord injury

Exclusion

Patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection)
Preexisting neurologic or spinal cord injury
Severe traumatic brain injury as measured by a best resuscitated Glasgow Coma Scale (GCS) score of \<8 at 24 hours following injury
Presence of traumatic injuries that preclude spine surgery within 24 hours of presentation
Concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke)
Preexisting history of neuromotor disorders (i.e., cerebral palsy, Parkinson disease, etc.)
Not expected to survive \>24h
Cord transection identified by radiologist and agreed upon by the spine surgery team
Injury below spinal cord level L1
Prisoners
Pregnant women

What this trial measures

  • The severity of a spinal cord injury (SCI) as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score6 weeks following injury

    Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome.

  • Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score6 weeks following injury

    There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome.