Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury (BIO-ProTECT)

December 2, 2014 updated by: Michael Frankel, Emory University

Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
576

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Health Center
      • Phoenix, Arizona, United States, 85251
        • Scottsdale Healthcare
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Medical Center
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
      • San Jose, California, United States, 95116
        • Regional Medical Ctr.-San Jose
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Shock Trauma
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai Grace Hospital
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Hospital
      • St. Paul, Minnesota, United States, 55101
        • Regions Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • St. Johns Mercy Medical Center
    • New York
      • New York, New York, United States, 10032
        • NYP Columbia
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Lukes Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional Medical Center/Elvis Presley Memorial Trauma Center
    • Texas
      • Austin, Texas, United States, 78752
        • Brackenridge Hospital
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froederdt Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
On progesterone treatment
The group assigned to progesterone treatment.
group assigned to placebo
The group that will not be receiving progesterone treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
Time Frame: Baseline, 24 hours, 48 hours
Blood will be collected/processed at baseline, 24 hours and 48 hours.
Baseline, 24 hours, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Frankel, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00014409a
  • 1R01NS071867 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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