RecruitingNot Applicable

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 range18 Years

SexALL

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

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

Timeframe: 6 weeks following injury

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-15

Contact for this trial

David Meyer, MD, MS, FACS

(713) 500-7244 David.E.Meyer@uth.tmc.edu

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 6 weeks following injury

Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score

Timeframe: 6 weeks following injury