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

NCT05084352 | Recruiting

• 1 other identifier: HP-00087051
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult TBI patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21210, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Neeraj Badjatia, MD MSc

CONTACT

14103284515; nbadjatia@umm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurology

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 19, 2021
• Study Start: March 29, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)