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

Traumatic Brain Injury Clinical Trial

— RAPID-TBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084352
• Other study ID #: HP-00087051
• Status: Recruiting
• Start date: March 29, 2021
• Est. completion date: October 31, 2026

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: Neeraj Badjatia, MD MSc
• Phone: 14103284515
• Email: nbadjatia[@]umm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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