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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Neeraj Badjatia, MD MSc; Phone Number: 14103284515; Email: nbadjatia@umm.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21210
      • Recruiting
      • University of Maryland Medical Center
      • Contact: Neeraj Badjatia; Phone Number: 410-328-4515; Email: nbadjatia@umm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult TBI patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: HP-00087051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No