Traumatic Brain InjuryPhase 3ProTECTNCT00822900
Progesterone for the Treatment of Traumatic Brain Injury III
A Phase 3 study testing Progesterone in people with Traumatic Brain Injury, run by David Wright at 36 sites in United States.
Trial summary
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 882 participants
- Where
- 36 sitesUnited States
- Study dates
- Mar 2010to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Moderate to severe brain injury (GCS 12-4)
- Age 18 years or older
- Blunt, closed head injury
- Study drug initiated within 4 hours of injury
Who cannot join
- Non-Survivable injury
- Bilateral dilated unresponsive pupils
- Severe intoxication (ETOH > 250 mg %)
- Spinal cord injury with neurological deficits
- Inability to perform activities of daily living prior to injury
- Cardiopulmonary arrest
Show all 17Show fewer
- Status epilepticus on arrival
- Systolic blood pressure (SBP) < 90 on arrival or for at least 5 minutes prior to enrollment
- O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment
- Prisoner or ward of state
- Pregnant
- Active breast or reproductive organ cancers
- Known allergy to progesterone or intralipid components (egg yolk)
- Known history of clotting disorder
- Active thromboembolic event
- Concern for inability to follow up at 6 months
- Anyone listed in the Opt out registry
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Austin/Brackenridge
Austin, Texas, 78752
University of Maryland Shock Trauma
Baltimore, Maryland, 21201
St. Luke's Hospital
Bethlehem, Pennsylvania, 18017
University Hospital
Cincinnatti, Ohio, 45267
Geisinger Medical Center
Danville, Pennsylvania
Detroit Receiving Hospital
Detroit, Michigan, 48202
Henry Ford Hospital
Detroit, Michigan, 48202
Sinai Grace Hospital
Detroit, Michigan
Hurley Medical Center
Flint, Michigan, 48503
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Memorial Hermann
Houston, Texas, 77030
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Regional Medical Center/Elvis Presley Memorial Trauma Center (The MED)
Memphis, Tennessee
Froedtert East Hospital
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55414
Columbia New York Presbyterian Hospital
New York, New York, 10032
Santa Clara Valley Hospital
Palo Alto, California, 94304
Stanford Medical Center
Palo Alto, California, 94304
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Thomas Jefferson UniversityHospital
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Maricopa Integrated Health System
Phoenix, Arizona, 85008
Banner Good Samaritan
Phoenix, Arizona
Oregon Health Sciences University
Portland, Oregon, 97239
Virginia Commonwealth
Richmond, Virginia, 23298
North Memorial Hospital
Robbinsdale, Minnesota
Beaumont Royal Oak Hospital
Royal Oak, Michigan, 48073
Regions Hospital
Saint Paul, Minnesota, 55101
Brooke Army Medical Center
San Antonio, Texas
San Francisco General Hospital
San Francisco, California, 94110
Regional Medical Center-San Jose
San Jose, California
Scottsdale Healthcare
Scottsdale, Arizona
St. Johns Mercy Medical Center
St Louis, Missouri, 63141
University of Arizona Medical Center
Tuscon, Arizona, 85724
About this study
Official title: Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone.
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.
- Conditions
- Traumatic Brain Injury
- Being tested
- Progesterone, Placebo
- Keywords
- Trauma, Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.
PlaceboDrug
Placebo stock solution is the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid is based on the mg/kg/hr volume. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid is administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone will be combined with a 20% Intralipid mixture for infusion. Receives: Drug: Progesterone |
| Placebo | Placebo comparator | Placebo stock solution was the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid was based on the same mg/kg/hr volume that would be required if PROG had been in the vial. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid was administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table was used by the on-sight pharmacy to mix the correct "dose" for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The placebo will be combined with a 20% Intralipid mixture for infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)
A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.
Measured: 6 months post randomization
Secondary outcomes (11)
Mortality
Measured: 6 months
Disability Rating Scale
A measure of functional impairment, with complete recovery scored a 0 and vegetative state scored a 29.
Measured: 6 months
Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis
Phlebitis/Thrombophlebitis (not due to infiltration or misplacement of the IV)
Measured: within 6 months
Potentially Associated Adverse Events: Pulmonary Embolism
Pulmonary embolism - Events were defined based on either positive chest computed tomography (CT) scanning or ventilation/perfusion lung scan (V/Q).
Measured: within 6 months
Potentially Associated Adverse Events: Acute Ischemic Stroke
Acute ischemic stroke - Events were defined based on either positive computed tomography (CT) scanning, magnetic resonance imaging (MRI), or neurologist diagnosis of cerebrovascular accident (CVA)
Measured: within 6 months
Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)
DVT - Events were defined based on a positive Doppler ultrasound exam
Measured: within 6 months
Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level
Unexplained increased liver enzymes (e.g. not due to liver injury ) - Events were defined based on aspartate transaminase (AST) and alanine transaminase (ALT) levels > 500 U/L and/or total bilirubin levels > 2.0 mg/dL.
Measured: within 6 months
Potentially Associated Adverse Events: Sepsis
Sepsis - Events must have met Centers for Disease Control and Prevention (CDC) definition of sepsis. The definition includes that a patient ≤1 year of age has at least 1 of the following clinical signs or symptoms with no other recognized cause: fever (>38°C rectal), hypothermia (<37°C rectal), apnea, or bradycardia, and blood culture not done or no organisms detected in blood and no apparent infection at another site and physician institutes treatment for sepsis.
Measured: within 6 months
Potentially Associated Adverse Events: Pneumonia
Events must have met Centers for Disease Control and Prevention (CDC) definition of pneumonia. There are three specific types of pneumonia: clinically defined pneumonia, pneumonia with specific laboratory findings, and pneumonia in immunocompromised patients. There are specific algorithms to identify each pneumonia, which include x-ray findings, fever with no other cause, leukopenia or leukocytosis, altered mental status with no other cause (adults >70 years old), new onset of purulent sputum, change in character of sputum, increase respiratory secretions, increase suctioning requirements, new onset or worsening cough, dyspnea, tachypnea, rales, bronchial breath sounds, or worsening gas exchange, increased oxygen requirements, or increased ventilator demand). Also, labs can identify pneumonia such as positive growth in blood culture, positive Gram stain, and histopathologic exam evidence.
Measured: within 6 months
Potentially Associated Adverse Events: Central Nervous System (CNS) Infection
CNS infection - Events must have met Centers for Disease Control and Prevention (CDC) definition of CNS infection. The definition includes intracranial infection, Meningitis, ventriculitis, and spinal abscess without meningitis.
Measured: within 6 months
Potentially Associated Adverse Events: Myocardial Infarction (MI)
Myocardial infarction - Events were defined based on serial cardiac enzyme elevation consistent with MI and/or new ST elevation on electrocardiogram (ECG) consistent with MI. Potentially associated adverse events (those events which are included as outcome measures) were specifically defined per the protocol, and the classification of an event as a PAAE was determined by the site. The reported name of the associated event, however, was subject to clinical judgement and case details; these were then further coded by the Principal Investigator. Since these data points do not share the same definition, there is no reason to expect perfect concordance. (For example, the potentially associated adverse event of myocardial infarction may include MedDRA codes other than myocardial infarction.)
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startMar 2010
- Primary completionMay 2014
- Study completionJul 2014
Why it stopped: futility: low conditional power to demonstrate benefit of progesterone
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 882 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Wright
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, Neurological Emergencies Treatment Trials Network (NETT)
- Responsible party
- Sponsor-investigator, David Wright, Emory University
- Investigators
- David W Wright, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822900
- Sponsor's protocol ID
- IRB00014409
- Other IDs
- 1RO1 NS062778-01
- Acronym
- ProTECT
- Status last verified
- Dec 2015
- First submitted
- 14 Jan 2009
- Last updated
- 20 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.
PubMed 26464429Wright DW, Yeatts SD, Silbergleit R, Palesch YY, Hertzberg VS, Frankel M, Goldstein FC, Caveney AF, Howlett-Smith H, Bengelink EM, Manley GT, Merck LH, Janis LS, Barsan WG; NETT Investigators. Very early administration of progesterone for acute traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2457-66. doi: 10.1056/NEJMoa1404304. Epub 2014 Dec 10.
PubMed 25493974
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone.
- ClinicalTrials.gov ID
- NCT00822900
- Acronym / sponsor ID
- ProTECT / IRB00014409
- Conditions
- Traumatic Brain Injury
- Keywords
- Trauma, Brain Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: futility: low conditional power to demonstrate benefit of progesterone
- Enrolment
- 882 participants (actual)
- Lead sponsor
- David WrightUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, Neurological Emergencies Treatment Trials Network (NETT)
- Study start
- Mar 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 3 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: ProgesteroneFollowing a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone will be combined with a 20% Intralipid mixture for infusion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo stock solution was the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid was based on the same mg/kg/hr volume that would be required if PROG had been in the vial. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid was administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table was used by the on-sight pharmacy to mix the correct "dose" for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The placebo will be combined with a 20% Intralipid mixture for infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe brain injury (GCS 12-4)
- Age 18 years or older
- Blunt, closed head injury
- Study drug initiated within 4 hours of injury
Key exclusion criteria (17 listed)
- Non-Survivable injury
- Bilateral dilated unresponsive pupils
- Severe intoxication (ETOH > 250 mg %)
- Spinal cord injury with neurological deficits
- Inability to perform activities of daily living prior to injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneFollowing a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion. | Drug | Progesterone |
| PlaceboPlacebo stock solution is the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid is based on the mg/kg/hr volume. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid is administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. | Drug | Placebo |
Primary outcome
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)
Time frame: 6 months post randomization
A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.
11 secondary outcomes
Mortality
Time frame: 6 months
Disability Rating Scale
Time frame: 6 months
Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis
Time frame: within 6 months
Potentially Associated Adverse Events: Pulmonary Embolism
Time frame: within 6 months
Potentially Associated Adverse Events: Acute Ischemic Stroke
Time frame: within 6 months
Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)
Time frame: within 6 months
Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level
Time frame: within 6 months
Potentially Associated Adverse Events: Sepsis
Time frame: within 6 months
Potentially Associated Adverse Events: Pneumonia
Time frame: within 6 months
Potentially Associated Adverse Events: Central Nervous System (CNS) Infection
Time frame: within 6 months
Potentially Associated Adverse Events: Myocardial Infarction (MI)
Time frame: within 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26464429Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.
- Derived from this study: PubMed 25493974Wright DW, Yeatts SD, Silbergleit R, Palesch YY, Hertzberg VS, Frankel M, Goldstein FC, Caveney AF, Howlett-Smith H, Bengelink EM, Manley GT, Merck LH, Janis LS, Barsan WG; NETT Investigators. Very early administration of progesterone for acute traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2457-66. doi: 10.1056/NEJMoa1404304. Epub 2014 Dec 10.
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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.
David W Wright, MD principal investigator
Emory University
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progesterone in people with Traumatic Brain Injury, run by David Wright at 36 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE) (time frame: 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822900, which also lists 2 linked publications.
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 20 Jan 2016.