Status:
COMPLETED
A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents
Lead Sponsor:
Corewell Health South
Collaborating Sponsors:
Michigan State University
Conditions:
Concussion Post Syndrome
Eligibility:
All Genders
12-18 years
Phase:
EARLY_PHASE1
Brief Summary
The objective of this study is to evaluate the efficacy of magnesium in symptomatic reduction of mild traumatic brain injury in the adolescent population in the acute setting of injury.
Detailed Description
Introduction Mild traumatic brain injuries are a growing problem in sports, and are now becoming publicly relevant. Mild traumatic brain injuries account for 700,000 ED visits, hospitalizations, and d...
Eligibility Criteria
Inclusion
- • Age 12 to 18 years
- • Presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury.
- • GCS \> 13 on arrival.
Exclusion
- • Age \< 12 years or \> 18 years
- • Inability to provide informed consent
- • Vomiting \> 2 episodes following injury
- • Physical or mental disability hindering adequate response to assessment of symptoms
- • Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
- • Known brain mass, intracranial hemorrhage, skull fracture
- • Known contraindications to magnesium use
- • Known contraindication to Zofran use
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03475693
Start Date
September 1 2017
End Date
December 30 2019
Last Update
November 29 2024
Active Locations (1)
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1
Lakeland Regional Healthcare
Saint Joseph, Michigan, United States, 49085