Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
NCT ID: NCT01143064
Last Updated: 2024-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1195 participants
INTERVENTIONAL
2010-06-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Progesterone
Progesterone
Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Lipid emulsion without progestrone
Lipid emulsion without progesterone
Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Interventions
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Progesterone
Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Lipid emulsion without progesterone
Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weight from 45 to 135 kg, inclusive
3. Sustained a closed head trauma no more than 8 hours before start of study drug infusion
4. TBI diagnosed by history and clinical examination
5. Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
6. At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
7. Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
8. Indication for ICP monitoring
Exclusion Criteria
2. Prolonged and/or uncorrectable hypoxia (Pa02\< 60 mmHg) or hypotension (systolic blood pressure \< 90 mmHg) at the time of randomization
3. Any spinal cord injury
4. Pregnancy
5. Penetrating head injury
6. Bilaterally fixed dilated pupils at the time of randomization
7. Coma suspected to be primarily due to other causes (e.g. alcohol)
8. Pure epidural hematoma
9. Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
10. Severe cardiac or hemodynamic instability prior to randomization
11. Known treatment with another investigational drug therapy or procedure within 30 days of injury
12. A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
13. Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
14. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
16 Years
70 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
Syneos Health
OTHER
BHR Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Neta R. Nelson, MPH
Role: STUDY_DIRECTOR
BHR Pharma, LLC
Locations
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University of South Alabama Medical Center
Mobile, Alabama, United States
LAC+USC Medical Center
Los Angeles, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Christiana Care Health System Hospital
Newark, Delaware, United States
Delray Medical Center
Delray Beach, Florida, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Saint John's Hospital
Springfield, Illinois, United States
Wishard Health Services
Indianapolis, Indiana, United States
Methodist Hospital
Indianapolis, Indiana, United States
Mercy Medical Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
LSU Health - Shreveport
Shreveport, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Medical Center
Portland, Maine, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
St. Mary's of Michigan
Saginaw, Michigan, United States
University of Missouri Health Care
Columbia, Missouri, United States
Truman Medical Center Hospital Hill
Kansas City, Missouri, United States
Lester E. Cox Memorial Hospital
Springfield, Missouri, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Albany Medical Center Hospital
Albany, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University-Baptist Medical Center
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
OU Medical Center
Oklahoma City, Oklahoma, United States
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of South Carolina School of Medicine
Columbia, South Carolina, United States
Johnson City Medical Center
Johnson City, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Hospital Francisco Lopez Lima
General Roca, Río Negro Province, Argentina
Hospital de Emergencias Clemente Alvarez (HECA)
Rosario, Santa Fe Province, Argentina
Hospital Nacional "Profesor Alejandro Posadas"
Buenos Aires, , Argentina
Hospital Regional De Comodoro Rivadavia (HRCR)
Comodoro Rivadavia, , Argentina
Hospital Central de Mendoza
Mendoza, , Argentina
Hospital San Martin
Paraná, , Argentina
Hospital Dr. José Maria Cullen
Santa Fé, , Argentina
Medizinische Universität Graz
Graz, , Austria
Medizinische Universität Innsbruck
Innsbruck, , Austria
Unfallkrankenhaus Salzburg
Salzburg, , Austria
Landesklinikum Wiener Neustadt
Vienna, , Austria
ULB Erasme
Brussels, , Belgium
Ziekenhuis Oost-Limburg, Location Sint Jan
Genk, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
University Hospital of the Free University Brussels (UZ Brussel)
Jette, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Chengdu Military General Hospital
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
The 2nd Affiliated Hospital of Zhejiang University
Hangzhou, , China
The Second Hospital of Shandong University
Jinan, , China
Huashan Hospital of Fudan University
Shanghai, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
General Hospital of Tianjin Medical University
Tianjin, , China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, , China
Fakultní nemocnice Brno Neurochirurgická klinika
Brno, , Czechia
Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika
Brno, , Czechia
Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení
Pilsen, , Czechia
Fakultní nemocnice Kralovske Vinohrady
Prague, , Czechia
Tampere University Hospital
Tampere, , Finland
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hôpital Pierre Wertheimer
Bron, , France
Centre Hospitalier Universitaire de Grenoble- Hópital Michallon
La Tronche, , France
CHRU de Lille- Hópital Roger Salengro
Lille, , France
Centre Hospitalier Universitaire de Limoges
Limoges, , France
Centre Hospitalier Universitaire Hôpital Nord
Marseille, , France
Hópital Central - CHU de Nancy
Nancy, , France
Groupe Hospitalier La Salpêtrière
Paris, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Krankenhaus Merheim
Cologne, , Germany
Klinikum der J.W. Goethe-Universität
Frankfurt, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Berufsgenossenschaftliche Kliniken
Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Gießen und Marburg gGmbH
Marburg, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Niels-Stensen-Kliniken
Osnabrück, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Honvédelmi Minisztérium Állami Egészségügyi Központ
Budapest, , Hungary
Pécsi Tudományegyetem Általános Orvostudományi Kar
Pécs, , Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, , Hungary
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, , Italy
Fondazione San Raffaele del Monte Tabor
Milan, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
Azienda Ospedaliero Universitaria Maggiore della Caritá
Novara, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
Azienda Ospedaliero Universitaria Integrata di Verona
Verona, , Italy
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
VU Medisch Centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, , Romania
State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development"
Kemerovo, , Russia
State Professional Institution of High Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development"
Krasnoyarsk, , Russia
State Institution "Burdenko Neurosurgical Institute of RAMS"
Moscow, , Russia
State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin"
Murmansk, , Russia
Saint Petersburg Healthcare Institution "City Mariinsky Hospital"
Saint Petersburg, , Russia
State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1"
Yekaterinburg, , Russia
National Neuroscience Institute
Singapore, , Singapore
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Universitario Vall Hebrón
Barcelona, , Spain
Hospital Universitario de Girona Dr. Josep Trueta
Girona, , Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario De Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chiang Mai University
Chiang Mai, , Thailand
Faculty of Medicine, Prince of Songkla University
Hat Yai, , Thailand
Khon Kaen Hospital
Khon Kaen, , Thailand
Royal Preston Hospital
Fulwood, Preston, United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Leeds Teaching Hospitals NHS, Leeds General Infirmary
Leeds, , United Kingdom
The Royal London Hospital
London, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
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References
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Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007 Apr;49(4):391-402, 402.e1-2. doi: 10.1016/j.annemergmed.2006.07.932. Epub 2006 Sep 29.
Xiao G, Wei J, Yan W, Wang W, Lu Z. Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Crit Care. 2008;12(2):R61. doi: 10.1186/cc6887. Epub 2008 Apr 30.
Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, MacAllister T, Ward JD, Nelson NR, Stocchetti N; SYNAPSE Trial Investigators. A clinical trial of progesterone for severe traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2467-76. doi: 10.1056/NEJMoa1411090. Epub 2014 Dec 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial website
Other Identifiers
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2010-018283-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BHR-100-301
Identifier Type: -
Identifier Source: org_study_id
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