Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— BIO-ProTECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01730443
• Other study ID #: IRB00014409a
• Secondary ID: 1R01NS071867
• Status: Terminated
• Phase: N/A
• First received: July 26, 2011
• Last updated: December 2, 2014
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 576
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Brackenridge Hospital	Austin	Texas
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Maryland Shock Trauma	Baltimore	Maryland
United States	St. Lukes Hospital	Bethlehem	Pennsylvania
United States	University Hospital	Cincinnati	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Detroit Receiving	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Sinai Grace Hospital	Detroit	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Hermann Hospital	Houston	Texas
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	Regional Medical Center/Elvis Presley Memorial Trauma Center	Memphis	Tennessee
United States	Froederdt Memorial Hospital	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	NYP Columbia	New York	New York
United States	Stanford Medical Center	Palo Alto	California
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Jefferson Hospital	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Health Center	Phoenix	Arizona
United States	Maricopa Integrated Health System	Phoenix	Arizona
United States	Scottsdale Healthcare	Phoenix	Arizona
United States	Oregon Health Sciences University	Portland	Oregon
United States	Virginia Commonwealth	Richmond	Virginia
United States	North Memorial Hospital	Robbinsdale	Minnesota
United States	Beaumont Health System	Royal Oak	Michigan
United States	Brooke Army Medical Center	San Antonio	Texas
United States	San Francisco General Hospital	San Francisco	California
United States	Regional Medical Ctr.-San Jose	San Jose	California
United States	Santa Clara Valley Medical Center	San Jose	California
United States	St. Johns Mercy Medical Center	St. Louis	Missouri
United States	Regions Medical Center	St. Paul	Minnesota
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No