NCT06451133 · The University of Texas Health Science Center, Houston
Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
What this study is about
The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic side effects in the first 5 days following acute spinal cord injury (SCI).
View original scientific description
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
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pregnant women
Where
- Houston, Texas
Collaborators
Trauma Research and Combat Casualty Care Collaborative (TRC4)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 11, 2024 · Source of record for eligibility and locations