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Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury

Recruiting
Conditions
Traumatic Brain Injury
Registration Number
NCT05084352
Lead Sponsor
University of Maryland, Baltimore
Brief Summary

This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1200
Inclusion Criteria
  • Arrival to the hospital within 6 hours of injury
  • Age >= 18 years old
  • Patients with traumatic brain injury(TBI). TBI is defined as any alteration or loss of consciousness with or without positive head C.T findings.
Exclusion Criteria
  • Deemed to have a non-survivable TBI
  • Brain dead on arrival
  • Active substance abuse for opiates and cocaine as noted by admission toxicology screen.
  • Any thoracic or abdominal injury resulting in open surgical intervention
  • Pregnancy
  • Prisoners
  • Active military
  • Non - English speaking (due to necessity for consent in aims 2 and 3)
  • Age > 89 years

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Neurological DeclineFirst 48 hours of injury

Neurological decline is defined as a worsening in neurological status determined by a 2 point decline GCS, pupillary change, radiographic worsening defined by Rotterdam score, need for neurological or neurosurgical intervention (eg. treatment of seizure, raised ICP, hematoma evacuation)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Maryland Medical Center

🇺🇸

Baltimore, Maryland, United States

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