Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

The University of Texas System (UT)

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Mean arterial blood pressure (MAP) goal of 85-90 mmHg; Other: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg; Other: Mean arterial blood pressure (MAP) goal of ≥65 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT06451133

HSC-MS-24-0405

Details and patient eligibility

About

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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228 participants in 3 patient groups

Mean arterial blood pressure (MAP) goal of ≥65 mmHg

Experimental group

Treatment:

Other: Mean arterial blood pressure (MAP) goal of ≥65 mmHg

Mean arterial blood pressure (MAP) goal of 85-90 mmHg

Experimental group

Treatment:

Other: Mean arterial blood pressure (MAP) goal of 85-90 mmHg

Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg

Experimental group

Treatment:

Other: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg