Recruiting

Hemodynamics ManagementHemodynamic Management Following Acute Traumatic Spinal Cord Injury

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06451133

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

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

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Study ID

NCT06451133

Start date

Jul 3, 2024

Status verified date

Dec, 2024

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Sep 15, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

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

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

The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.

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 ]
Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score [ Time Frame: 6 weeks following injury ]

Central Contacts and Locations

Central contacts

David Meyer, MD, MS, FACS

(713) 500-7244 David.E.Meyer@uth.tmc.edu

Erin Fox

(713) 500-6273 Erin.E.Fox@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

David Meyer, MD, MS, FACS

713-500-7244 David.E.Meyer@uth.tmc.edu

Erin Fox

(713) 500-6273 Erin.E.Fox@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-11.