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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.