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Recruiting NCT06451133

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

No phase Interventional Spinal Cord Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: 6 months following injury, 12 months following injury]
  • Number of ICU-free days [Time frame: 30 days from baseline]
  • Duration of time (hours) receiving goal caloric requirements by enteric nutrition [Time frame: first 5 days of hospitalization]
  • Number of participants developing a central line-associated blood stream infection [Time frame: Baseline to hospital discharge or 30 days, whichever comes first]
  • Number of participants developing a pneumothorax from central venous catheter insertion [Time frame: Baseline to hospital discharge or 30 days, whichever comes first]
  • Number of participants developing pneumonia [Time frame: 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 [Time frame: Baseline to hospital discharge or 30 days, whichever comes first]
  • Number of deaths [Time frame: Baseline to hospital discharge or 30 days, whichever comes first]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06451133 · HSC-MS-24-0405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗