Real Time Vital Sign Assessment to Predict Neurological D... | NCT05084352

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

NCT05084352

Sponsor

University of Maryland, Baltimore

Status

Recruiting

Last Update Posted

May 15, 2025Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2021Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Oct 31, 2026Estimated

First Submitted Date

Sep 27, 2021

First Submission Date that Met QC Criteria

Oct 15, 2021

First Posted Date

Oct 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2025

Last Update Posted Date

May 15, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neeraj Badjatia, Professor, Department of Neurology, University of Maryland, BaltimorePrincipal Investigator

Lead Sponsor

University of Maryland, BaltimoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Adult TBI patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neeraj Badjatia, MD MSc	Contact	14103284515		nbadjatia@umm.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland Medical Center	Recruiting	Baltimore	Maryland	21210	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided