NCT06451133 Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
| NCT ID | NCT06451133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2024-07-03 |
| Primary Completion | 2025-09-15 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility 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