Hemodynamic Management Following Acute Traumatic Spinal Cord Injury
NCT ID: NCT06451133
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
228 participants
INTERVENTIONAL
2024-07-03
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mean arterial blood pressure (MAP) goal of ≥65 mmHg
Mean arterial blood pressure (MAP) goal of ≥65 mmHg
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
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.
Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.
Interventions
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Mean arterial blood pressure (MAP) goal of ≥65 mmHg
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
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
The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Trauma Research and Combat Casualty Care Collaborative (TRC4)
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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David E. Meyer, MD, MS, FACS
Associate Professor
Principal Investigators
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David Meyer, MD, MS, FACS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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David Meyer, MD, MS, FACS
Role: primary
Erin Fox
Role: backup
Other Identifiers
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HSC-MS-24-0405
Identifier Type: -
Identifier Source: org_study_id