Managing blood flow after spinal cord injuries
Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial
This study is testing different ways to manage blood flow in people with recent spinal cord injuries to see which method helps them recover better and avoid other health problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06451133 on ClinicalTrials.gov |
What this trial studies
This study evaluates different hemodynamic management strategies to improve functional neurologic outcomes and reduce non-neurologic adverse events in patients with acute spinal cord injuries. Participants will be assigned to one of three management strategies: targeting a mean arterial blood pressure (MAP) of 85-90 mmHg, a spinal cord perfusion pressure (SCPP) of ≥65 mmHg, or maintaining normal hemodynamics with a MAP of ≥65 mmHg. The assessment will occur within the first five days following the injury to determine the effectiveness of these approaches.
Who should consider this trial
Good fit: Ideal candidates are individuals who have sustained a traumatic spinal cord injury.
Not a fit: Patients with penetrating spinal cord injuries or severe preexisting conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for patients with acute spinal cord injuries.
How similar studies have performed: Other studies have explored hemodynamic management in spinal cord injuries, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Meyer, MD, MS, FACS — The University of Texas Health Science Center, Houston
- Study coordinator: David Meyer, MD, MS, FACS
- Email: David.E.Meyer@uth.tmc.edu
- Phone: (713) 500-7244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.