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NCT Number: NCT06451133

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Secondary outcomes

  1. 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

    Time frame: 6 months following injury, 12 months following injury

    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.

  2. 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

    Time frame: 6 months following injury, 12 months following injury

    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.

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

    Time frame: 6 months following injury, 12 months following injury

    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.

  4. Number of ICU-free days

    Time frame: 30 days from baseline

    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.

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

    Time frame: first 5 days of hospitalization

  6. Number of participants developing a central line-associated blood stream infection

    Time frame: Baseline to hospital discharge or 30 days, whichever comes first

    Blood stream infection is defined as bacteremia confirmed by blood culture in the presence of a central venous catheter.

  7. Number of participants developing a pneumothorax from central venous catheter insertion

    Time frame: Baseline to hospital discharge or 30 days, whichever comes first

  8. Number of participants developing pneumonia

    Time frame: Baseline to hospital discharge or 30 days, whichever comes first

    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.

  9. Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria

    Time frame: Baseline to hospital discharge or 30 days, whichever comes first

    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.

  10. Number of deaths

    Time frame: Baseline to hospital discharge or 30 days, whichever comes first

Study contacts

Contact information is provided by the study sponsor or research team.

David Meyer, MD, MS, FACS

CONTACT

[email protected]

(713) 500-7244

Erin Fox

CONTACT

[email protected]

(713) 500-6273

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Trauma Research and Combat Casualty Care Collaborative (TRC4)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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