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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05084352
Acronym
RAPID-TBI
Enrollment
1200
Registered
2021-10-19
Start date
2021-03-29
Completion date
2026-08-31
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

None listed

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Neurological DeclineFirst 48 hours of injuryNeurological 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026