Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06451133
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Dec 2024
Primary completion
Sep 15, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

The severity of a spinal cord injury (SCI) as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score [ Time Frame: 6 weeks following injury ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
David Meyer, MD, MS, FACS
[email protected]
713-500-7244
Erin Fox
[email protected]
(713) 500-6273

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The University of Texas Health Science Center at Houston· Houston, TX

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