Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury (BIO-ProTECT)
This study has been terminated.
(Parent trial (ProTECT III) stopped for futility)
Information provided by (Responsible Party):
Michael Frankel, Emory University
First received: July 26, 2011
Last updated: December 2, 2014
Last verified: December 2014
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.
||Observational Model: Case-Only
Time Perspective: Prospective
||Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
with consent there will be long term storage of serum for Non-DNA testing
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
On progesterone treatment
The group assigned to progesterone treatment.
group assigned to placebo
The group that will not be receiving progesterone treatment
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients with a moderate to severe blunt traumatic brain injury who meet the inclusion and exclusion criteria for the ProTECT III study.
- 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 -
- 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 -
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730443
||Michael Frankel, MD
No publications provided
||Michael Frankel, Professor, Emory University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 26, 2011
||December 2, 2014
||United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board
Keywords provided by Emory University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries