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

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.

Completed

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21210, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Neurological Decline

Time frame: First 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)

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Acronym: RAPID-TBI

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Oct 19, 2021
Registry last updated: Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed