Traumatic Brain InjuryBIO-ProTECTNCT01730443
Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by Emory University at 37 sites in United States.
Trial summary
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 576 participants
- Where
- 37 sitesUnited States
- Study dates
- Jul 2011to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 17Show fewer
- 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 -
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Brackenridge Hospital
Austin, Texas, 78752
University of Maryland Shock Trauma
Baltimore, Maryland, 21201
Johns Hopkins
Baltimore, Maryland, 21287
St. Lukes Hospital
Bethlehem, Pennsylvania, 18015
University Hospital
Cincinnati, Ohio, 45267
Geisinger Medical Center
Danville, Pennsylvania, 17822
Detroit Receiving
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Sinai Grace Hospital
Detroit, Michigan, 48235
Hurley Medical Center
Flint, Michigan, 48503
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Hermann Hospital
Houston, Texas, 77030
University of Kentucky Hospital
Lexington, Kentucky, 40536
Regional Medical Center/Elvis Presley Memorial Trauma Center
Memphis, Tennessee, 38103
Froederdt Memorial Hospital
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
NYP Columbia
New York, New York, 10032
Stanford Medical Center
Palo Alto, California, 94305
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Temple University
Philadelphia, Pennsylvania, 19122
Banner Good Samaritan Health Center
Phoenix, Arizona, 85006
Maricopa Integrated Health System
Phoenix, Arizona, 85008
Scottsdale Healthcare
Phoenix, Arizona, 85251
Oregon Health Sciences University
Portland, Oregon, 97239
Virginia Commonwealth
Richmond, Virginia, 23298
North Memorial Hospital
Robbinsdale, Minnesota, 55422
Beaumont Health System
Royal Oak, Michigan, 48073
Regions Medical Center
Saint Paul, Minnesota, 55101
Brooke Army Medical Center
San Antonio, Texas, 78234
San Francisco General Hospital
San Francisco, California, 94110
Regional Medical Ctr.-San Jose
San Jose, California, 95116
Santa Clara Valley Medical Center
San Jose, California, 95128
St. Johns Mercy Medical Center
St Louis, Missouri, 63141
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| On progesterone treatment | The group assigned to progesterone treatment. | |
| group assigned to placebo | The group that will not be receiving progesterone treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 24 hours, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionMay 2014
- Study completionJul 2014
Why it stopped: Parent trial (ProTECT III) stopped for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Frankel, Emory University
- Investigators
- Michael Frankel, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730443
- Sponsor's protocol ID
- IRB00014409a
- Other IDs
- 1R01NS071867
- Acronym
- BIO-ProTECT
- Status last verified
- Dec 2014
- First submitted
- 26 Jul 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
- ClinicalTrials.gov ID
- NCT01730443
- Acronym / sponsor ID
- BIO-ProTECT / IRB00014409a
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Parent trial (ProTECT III) stopped for futility
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On progesterone treatment | – | –The group assigned to progesterone treatment. |
| group assigned to placebo | – | –The group that will not be receiving progesterone treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Parent trial (ProTECT III) stopped for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Frankel, MD principal investigator
Emory University
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Emory University at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Parent trial (ProTECT III) stopped for futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.