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

NCT ID: NCT05084352

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Neeraj Badjatia

Professor, Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neeraj Badjatia, MD MSc

Role: CONTACT

14103284515

Facility Contacts

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Neeraj Badjatia

Role: primary

4103284515

Other Identifiers

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HP-00087051

Identifier Type: -

Identifier Source: org_study_id

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