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Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

Information source: BHR Pharma, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Injuries

Intervention: Progesterone (Drug); Lipid emulsion without progesterone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: BHR Pharma, LLC

Official(s) and/or principal investigator(s):
Neta R. Nelson, MPH, Study Director, Affiliation: BHR Pharma, LLC

Summary

The SyNAPSe trial will study if giving intravenous (i. v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Glasgow Outcome Scale (GOS)

Secondary outcome:

Mortality

Glasgow Outcome Scale

Glasgow Outcome Scale - Extended (GOS-E)

Short Form (36) Health Survey (SF-36)

Effect of progesterone on Intracranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and Therapeutic Intensity Level (TIL)

Effect of progesterone on the progression of intracranial pathology

Eligibility

Minimum age: 16 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female patients between the age of 16 and 70 years, inclusive 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: 1. Life expectancy of less than 24 hours as determined by the Investigator 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)

Locations and Contacts

Hospital Central de Mendoza, Mendoza, Argentina

Hospital San Martin, Paraná, Argentina

Hospital Nacional "Profesor Alejandro Posadas", Provincia de Buenos Aires, Argentina

Hospital Regional De Comodoro Rivadavia (HRCR), Provincia de Chubut, 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, Gent, 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, Czech Republic

Fakultní nemocnice u sv. Anny v Brnĕ, Neurochirurgická klinika, Brno, Czech Republic

Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení, Plzeň, Czech Republic

Fakultní nemocnice Kralovske Vinohrady, Praha, Czech Republic

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

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

Krankenhaus Merheim, Köln, Germany

Universitätsklinikum Gießen und Marburg gGmbH, Marburg, Germany

Klinikum Nürnberg, Nürnberg, 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, Petach-Tikva, Israel

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Chaim Sheba Medical Center, Tel-Hashomer, Israel

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milano, Italy

Fondazione San Raffaele del Monte Tabor, Milano, 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, Perak, Malaysia

Hospital Kuala Lumpur, Kuala Lumpur, Malaysia

University Malaya Medical Centre, Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia

Sarawak General Hospital, Kuching, Sarawak, Malaysia

VU Medisch Centrum, Amsterdam, Netherlands

Universitair Medisch Centrum Groningen, Groningen, Netherlands

Spitalul Clinic Judetean de Urgenta Timisoara, Timisoara, Romania

State Budget Educational Institution of Higher Professional Education "Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development", Kemerovo, Russian Federation

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, Russian Federation

State Institution "Burdenko Neurosurgical Institute of RAMS", Moscow, Russian Federation

State Healthcare Facility "Murmansk Regional Clinical Hospital n.a. Bayandin", Murmansk, Russian Federation

Saint Petersburg Healthcare Institution "City Mariinsky Hospital", St. Petersburg, Russian Federation

State Institution of Health Care "Sverdlovsk Regional Clinical Hospital #1", Yekaterinburg, Russian Federation

National Neuroscience Institute, Singapore, Singapore

National University Hospital, Singapore, Singapore

Singapore General Hospital, Singapore, Singapore

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, Sevilla, 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

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

University of South Alabama Medical Center, Mobile, Alabama 36617, United States

Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain

Hospital Parc Taulí, Sabadell, Barcelona, Spain

LAC+USC Medical Center, Los Angeles, California 90033, United States

University of California San Diego Medical Center, San Diego, California 92103, United States

Denver Health Medical Center, Denver, Colorado 80204, United States

Christiana Care Health System Hospital, Newark, Delaware 19718, United States

Delray Medical Center, Delray Beach, Florida 33431, United States

Tallahassee Memorial Healthcare, Tallahassee, Florida 32308, United States

Tampa General Hospital, Tampa, Florida 33606, United States

Saint Alphonsus Regional Medical Center, Boise, Idaho 83706, United States

John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois 60612, United States

Advocate Lutheran General Hospital, Park Ridge, Illinois 60068, United States

Saint John's Hospital, Springfield, Illinois 62769, United States

Methodist Hospital, Indianapolis, Indiana 46206, United States

Wishard Health Services, Indianapolis, Indiana 46202, United States

Mercy Medical Center, Des Moines, Iowa 50314, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

University of Louisville Hospital, Louisville, Kentucky 40202, United States

LSU Health - Shreveport, Shreveport, Louisiana 71103, United States

Eastern Maine Medical Center, Bangor, Maine 04401, United States

Maine Medical Center, Portland, Maine 04102, United States

Baystate Medical Center, Springfield, Massachusetts 01199, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States

St. Mary's of Michigan, Saginaw, Michigan 48604, United States

University of Missouri Health Care, Columbia, Missouri 65212, United States

Truman Medical Center Hospital Hill, Kansas City, Missouri 64108, United States

Lester E. Cox Memorial Hospital, Springfield, Missouri 65804, United States

The Nebraska Medical Center, Omaha, Nebraska 68198, United States

Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08903, United States

Albany Medical Center Hospital, Albany, New York 12208, United States

Westchester Medical Center, Valhalla, New York 10595, United States

Mission Hospital, Asheville, North Carolina 28801, United States

Carolinas Medical Center, Charlotte, North Carolina 28203, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Wake Forest University-Baptist Medical Center, Winston-Salem, North Carolina 27157, United States

Summa Health System, Akron, Ohio 44304, United States

MetroHealth Medical Center, Cleveland, Ohio 44109, United States

Miami Valley Hospital, Dayton, Ohio 45409, United States

St. Elizabeth Health Center, Youngstown, Ohio 44501, United States

OU Medical Center, Oklahoma City, Oklahoma 73104, United States

Legacy Emanuel Hospital & Health Center, Portland, Oregon 97227, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Royal Preston Hospital, Fulwood, Preston, United Kingdom

Hospital Francisco Lopez Lima, General Roca, Rio Negro, Argentina

Hospital de Emergencias Clemente Alvarez (HECA), Rosario, Santa Fe, Argentina

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University of South Carolina School of Medicine, Columbia, South Carolina 29203, United States

Johnson City Medical Center, Johnson City, Tennessee 37604, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37212, United States

Texas Tech University Health Sciences Center, El Paso, Texas 79905, United States

University of Virginia Health System, Charlottesville, Virginia 22908, United States

Marshall University Joan C. Edwards School of Medicine, Huntington, West Virginia 25701, United States

West Virginia University Hospital, Morgantown, West Virginia 26506, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States

Additional Information

Sponsor website

Trial website

Related publications:

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. 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.

Starting date: June 2010
Last updated: June 11, 2014

Page last updated: August 23, 2015

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