Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

Purpose

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.

Condition

  • Spinal Cord Injuries

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mean arterial blood pressure (MAP) goal of ≥65 mmHg
  • Other: Mean arterial blood pressure (MAP) goal of ≥65 mmHg
    The treatment team will maintain MAP ≥65 mmHg for the first five days following injury.
Experimental
Mean arterial blood pressure (MAP) goal of 85-90 mmHg
  • Other: Mean arterial blood pressure (MAP) goal of 85-90 mmHg
    The treatment team will maintain MAP 85-90 mmHg for the first five days following injury.
Experimental
Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
  • Other: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
    The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
David Meyer, MD, MS, FACS
713-500-7244
David.E.Meyer@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

David Meyer, MD, MS, FACS
(713) 500-7244
David.E.Meyer@uth.tmc.edu