Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Mean arterial blood pressure (MAP) goal of ≥65 mmHg; Other: Mean arterial blood pressure (MAP) goal of 85-90 mmHg; Other: Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Meyer, MD, MS, FACS; Phone Number: (713) 500-7244; Email: David.E.Meyer@uth.tmc.edu
• Study Contact Backup: Name: Erin Fox; Phone Number: (713) 500-6273; Email: Erin.E.Fox@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Erin Fox; Phone Number: (713) 500-6273; Email: Erin.E.Fox@uth.tmc.edu
      • Contact: David Meyer, MD, MS, FACS; Phone Number: 713-500-7244; Email: David.E.Meyer@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 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	For each side of the body, 28 key sensory points will be assessed by light touch, and each area will be scored from 0 to 2 (0 indicates sensing is absent, 1 indicates sensing is altered, and 2 indicates that sensing is normal). Additionally, for each side of the body 28 key sensory points will be also be assessed by pin prick, and each area will be scored from 0 to 2 (0 indicates sensing is absent, 1 indicates sensing is altered, and 2 indicates that sensing is normal). Scores for light touch and pin prick assessments for both sides of the body will be combined, and the total score ranges from 0 to 224, with a higher score indicating a better outcome.	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	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 months following injury, 12 months following injury
Number of ICU-free days	Number of ICU-free days = [30 days - ICU length of stay in days]. Patients with ICU length of stay >30 days will be assigned a value of zero ICU-free days.	30 days from baseline
Duration of time (hours) receiving goal caloric requirements by enteric nutrition		first 5 days of hospitalization
Number of participants developing a central line-associated blood stream infection	Blood stream infection is defined as bacteremia confirmed by blood culture in the presence of a central venous catheter.	Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing a pneumothorax from central venous catheter insertion		Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing pneumonia	Pneumonia is defined as 10,000 colony forming units (cfu)/milliliter (mL) on bronchioalveolar lavage or mini bronchioalveolar lavage, or clinical diagnosis of pneumonia with subsequent antibiotic treatment.	Baseline to hospital discharge or 30 days, whichever comes first
Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria	Acute kidney injury using the RIFLE criteria is defined as a 50% increase in serum creatinine from baseline or urine output <0.5 mL/h for 6 hours.	Baseline to hospital discharge or 30 days, whichever comes first
Number of deaths		Baseline to hospital discharge or 30 days, whichever comes first

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Trauma Research and Combat Casualty Care Collaborative (TRC4)
• Investigators: Principal Investigator: David Meyer, MD, MS, FACS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: HSC-MS-24-0405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No