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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05084352
Other study ID # HP-00087051
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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