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Clinical Trial NCT05084352 (RAPID-TBI) for Traumatic Brain Injury is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury (RAPID-TBI) 1,200

Recruiting
Clinical Trial NCT05084352 (RAPID-TBI) is an observational study for Traumatic Brain Injury that is recruiting. It started on March 29, 2021 with plans to enroll 1,200 participants. Led by University of Maryland, Baltimore, it is expected to complete by October 31, 2026. The latest data from ClinicalTrials.gov was last updated on May 15, 2025.
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.
Official Title

Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury (RAPID-TBI)

Conditions
Traumatic Brain Injury
Other Study IDs
  • RAPID-TBI
  • HP-00087051
NCT ID Number
NCT05084352
Start Date (Actual)
2021-03-29
Last Update Posted
2025-05-15
Completion Date (Estimated)
2026-10-31
Enrollment (Estimated)
1,200
Study Type
Observational
Status
Recruiting
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Neurological Decline
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)
First 48 hours of injury
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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
University of Maryland, Baltimore logoUniversity of Maryland, Baltimore199 active studies to explore
Study Responsible Party
Neeraj Badjatia, Principal Investigator, Professor, Department of Neurology, University of Maryland, Baltimore
Study Central Contact
Contact: Neeraj Badjatia, MD MSc, 14103284515, [email protected]
1 Study Locations in 1 Countries

Maryland

University of Maryland Medical Center, Baltimore, Maryland, 21210, United States
Neeraj Badjatia, Contact, 4103284515, [email protected]
Recruiting