Clinical trial NCT06451133: Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
Official title: Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Trauma Research and Combat Casualty Care Collaborative (TRC4)
First posted: 2024-06-11
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: 6 weeks following injury
measure: Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
timeFrame: 6 weeks following injury
Secondary outcomes:
measure: 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
timeFrame: 6 months following injury, 12 months following injury
measure: 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
timeFrame: 6 months following injury, 12 months following injury
measure: Change in performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
timeFrame: 6 months following injury, 12 months following injury
measure: Number of ICU-free days
timeFrame: 30 days from baseline
measure: Duration of time (hours) receiving goal caloric requirements by enteric nutrition
timeFrame: first 5 days of hospitalization
measure: Number of participants developing a central line-associated blood stream infection
timeFrame: Baseline to hospital discharge or 30 days, whichever comes first
measure: Number of participants developing a pneumothorax from central venous catheter insertion
timeFrame: Baseline to hospital discharge or 30 days, whichever comes first
measure: Number of participants developing pneumonia
timeFrame: Baseline to hospital discharge or 30 days, whichever comes first
measure: Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria
timeFrame: Baseline to hospital discharge or 30 days, whichever comes first
measure: Number of deaths
timeFrame: Baseline to hospital discharge or 30 days, whichever comes first
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David Meyer, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References: