Blood Biomarkers of Injury and Outcome in Traumatic Brain... | NCT01730443

ID	Type	Description	Link
1R01NS071867	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Parent trial (ProTECT III) stopped for futility

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

May 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jul 26, 2011

First Submission Date that Met QC Criteria

Nov 15, 2012

First Posted Date

Nov 21, 2012Estimated

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

Dec 2, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.

Detailed Description

Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study just prior to the initiation of the study drug infusion and 24 and 48 hours from the time they are enrolled in the study to test for biomarkers that may help predict how severe the injury is and how well they improve. The investigators will also test to see if the study medication is being absorbed and is staying at a consistent level in the blood stream.

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

576Actual

Label	Type	Description	Intervention Names
On progesterone treatment		The group assigned to progesterone treatment.
group assigned to placebo		The group that will not be receiving progesterone treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.	Blood will be collected/processed at baseline, 24 hours and 48 hours.	Baseline, 24 hours, 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe brain injury (iGCS 12-4 or motor response 2-5 if intubated).
Age >18 years (or developmental stage Tanner 5 in patients where age is not known)
Blunt, traumatic, closed head injury (altered mental status due to brain injury)
Able to initiate study drug infusion within 4 hours from time of injury -

Exclusion Criteria:

Non-survivable injury as determined by treating
Bilateral dilated unresponsive pupils
Spinal cord injury with neurological deficits, pre-injury paralysis (quad/paraplegic)
Inability to perform activities of daily living (ADL) without assistance
Cardiopulmonary arrest
Status epilepticus on arrival or concern for post ictal state
systolic blood pressure < 90 for two consecutive readings at least 5 minutes apart any time prior to randomization
O2 Sat < 90 for at least 5 consecutive minutes any time prior to randomization
Prisoner or ward of state
Known active breast or reproductive organ cancers (via medical records or family interview)
Known allergy to progesterone or Intralipid components (egg yolk) (via medical records or family interview)
Known history of blood clotting disorder (Protein S or C deficiency, etc.) or history of pulmonary embolism (via medical records or family interview) or active/ongoing thromboembolic event (myocardial infarction, ischemic stroke, pulmonary embolism, deep vein thrombosis).
Blood or serum ethanol (EtOH) ≥ 250 mg %
Positive qualitative urine or serum pregnancy test
Concern for inability to follow up at 6 months (residence in foreign country, homeless with limited contacts,
undocumented immigrants, or high likelihood of becoming incarcerated during study period, etc.)
Patient in Opt Out registry or wearing Opt Out bracelet -

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

patients with a moderate to severe blunt traumatic brain injury who meet the inclusion and exclusion criteria for the ProTECT III study.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Banner Good Samaritan Health Center		Phoenix	Arizona	85006	United States
Maricopa Integrated Health System

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D014947	Wounds and Injuries