Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

NCT06451133 | Recruiting DMC

• 1 other identifier: HSC-MS-24-0405
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome.

  6 weeks following injury

• Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score

  There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome.

  6 weeks following injury

Secondary Outcomes (10)

• Change in motor function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score

  6 months following injury, 12 months following injury

• Change in sensory function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) sensory score

  6 months following injury, 12 months following injury

• Change in performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score

  6 months following injury, 12 months following injury

• Number of ICU-free days

  30 days from baseline

• Duration of time (hours) receiving goal caloric requirements by enteric nutrition

  first 5 days of hospitalization

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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 ≥65 mmHg

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic spinal cord injury

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Trauma Research and Combat Casualty Care Collaborative (TRC4): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Meyer, MD, MS, FACS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Meyer, MD, MS, FACS

CONTACT

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

Erin Fox

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: July 3, 2024
• Primary Completion: September 15, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)