Biomarkers of Brain Injury: Magnitude and Outcome of Mild... | NCT01786447

Studies
Biomarkers of Brain Injury: Magnitude and Outcome of Mild and Moderate TBI

NCT01786447

Sponsor

Banyan Biomarkers, Inc

Status

Terminated

Last Update Posted

Feb 12, 2013Estimated

Enrollment

111Actual

Phase

Not provided

Conditions

Brain Injuries, Traumatic

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

Feb 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Feb 6, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 8, 2013Estimated

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

Feb 8, 2013

Last Update Posted Date

Feb 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if specific brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI as well as in orthopedic control subjects.

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

Retention

Enrollment

111Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traumatic Brain Injury		Patients who present to the health care facility with mild or moderate traumatic brain injury (Glasgow Coma Scale 9-15) within 4 hours of injury
Orthopedic Control		Patients who present to the health care facility with isolated extracranial orthopedic injury within 4 hours of injury

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of biomarkers to identify patients with TBI from orthopedic controls		4 hours

Secondary Outcomes

Measure	Description	Time Frame
Assessment of biomarkers to identify patients with brain lesions on CT scan		4 hours

Other Outcomes

Measure	Description	Time Frame
Assessment of biomarkers to identify patients with acute post-injury alterations in mental status		96 hours
Assessment of biomarkers to identify patients that may have longer-term post-injury neurological deficits using neuropsychological assessments		Day 30

Eligibility Module

Eligibility Criteria

Mild/Moderate TBI Group

Inclusion Criteria:

18 years or older
GCS 9-15
CT scan as part of clinical evaluation
experienced some level of altered mental state at time of injury
determination of study eligibility within 4 hours of injury

Exclusion Criteria:

Pregnant females
Prisoners
Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
no clear history of trauma as primary event
previous history of stroke, or head injury requiring hospitalization
dementia or psychotic illness or neurological condition which may affect outcome
unable to speak or understand English

Orthopedic Control Group

Inclusion Criteria:

18 years or older
Isolated extracranial orthopedic injury, including fractures
Stable vital signs on presentation to ED (pulse < 100bpm and systolic blood pressure > 100 mmHg)

Exclusion Criteria:

evidence of brain injury, including abnormal neurological examination, alteration in consciousness, memory or mental status, headache, dizziness, or vomiting following injury
not enrolled within 4 hours of injury
Pregnant females
Prisoners
Anemia or significant blood loss (hemoglobin < 12 mg/dL and/or hematocrit < 35%, and/or clinical state requiring resuscitation with more than 6L of colloid or crystalloid fluid)
previous history of stroke, or head injury requiring hospitalization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who present to the health care facility with either Traumatic Brain Injury (GCS 9-15) or isolated extracranial orthopedic injury within 4 hours of injury

Sampling Method

Non-Probability Sample

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