Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
United States228 participantsStarted 2024-07-03
Plain-language summary
The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (SCI). The hemodynamic management strategies assessed include targeting a mean arterial blood pressure (MAP) goal of 85-90 mmHg, targeting a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg, or targeting normal hemodynamics, which is a MAP goal of ≥65 mmHg.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Traumatic spinal cord injury
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 6 weeks following injury
2
Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
Timeframe: 6 weeks following injury
Trial details
NCT IDNCT06451133
SponsorThe University of Texas Health Science Center, Houston