Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial
The University of Texas Health Science Center, Houston
228 participants
Jul 3, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- Traumatic spinal cord injury
Exclusion Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The treatment team will maintain MAP ≥65 mmHg for the first five days following injury.
The treatment team will maintain MAP 85-90 mmHg for the first five days following injury.
The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06451133