Status:
ACTIVE_NOT_RECRUITING
A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.
Lead Sponsor:
Ohio State University
Conditions:
Trauma, Spinal Cord
SPINAL Fracture
Eligibility:
All Genders
18+ years
Brief Summary
The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impa...
Eligibility Criteria
Inclusion
- Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment
- Patients with acute isolated spinal fracture, lesion may include more than 1 segment
- Legal age of the patient
- Documented informed consent of the patient
Exclusion
- Non-traumatic spinal cord injury
- Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors)
- Neoplasia and/or antineoplastic therapy
- Pregnancy, lactation
Key Trial Info
Start Date :
September 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03253952
Start Date
September 29 2017
End Date
December 31 2027
Last Update
August 11 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210