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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,195

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Brain Injuries
Interventions
DRUG

Progesterone

Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

DRUG

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.

Trial Locations (156)

10595

Westchester Medical Center, Valhalla

12208

Albany Medical Center Hospital, Albany

15212

Allegheny General Hospital, Pittsburgh

15213

University of Pittsburgh Medical Center, Pittsburgh

19718

Christiana Care Health System Hospital, Newark

22908

University of Virginia Health System, Charlottesville

25701

Marshall University Joan C. Edwards School of Medicine, Huntington

26506

West Virginia University Hospital, Morgantown

27157

Wake Forest University-Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center, Charlotte

28801

Mission Hospital, Asheville

29203

University of South Carolina School of Medicine, Columbia

29425

Medical University of South Carolina, Charleston

32308

Tallahassee Memorial Healthcare, Tallahassee

33431

Delray Medical Center, Delray Beach

33606

Tampa General Hospital, Tampa

36617

University of South Alabama Medical Center, Mobile

37212

Vanderbilt University Medical Center, Nashville

37604

Johnson City Medical Center, Johnson City

40202

University of Louisville Hospital, Louisville

44109

MetroHealth Medical Center, Cleveland

44304

Summa Health System, Akron

44501

St. Elizabeth Health Center, Youngstown

45409

Miami Valley Hospital, Dayton

46202

Wishard Health Services, Indianapolis

46206

Methodist Hospital, Indianapolis

48604

St. Mary's of Michigan, Saginaw

49007

Bronson Methodist Hospital, Kalamazoo

50314

Mercy Medical Center, Des Moines

52242

University of Iowa Hospitals and Clinics, Iowa City

53792

University of Wisconsin Hospital and Clinics, Madison

60068

Advocate Lutheran General Hospital, Park Ridge

60612

John H. Stroger Jr. Hospital of Cook County, Chicago

62769

Saint John's Hospital, Springfield

64108

Truman Medical Center Hospital Hill, Kansas City

65212

University of Missouri Health Care, Columbia

65804

Lester E. Cox Memorial Hospital, Springfield

66160

University of Kansas Medical Center, Kansas City

68198

The Nebraska Medical Center, Omaha

71103

LSU Health - Shreveport, Shreveport

73104

OU Medical Center, Oklahoma City

79905

Texas Tech University Health Sciences Center, El Paso

80204

Denver Health Medical Center, Denver

83706

Saint Alphonsus Regional Medical Center, Boise

90033

LAC+USC Medical Center, Los Angeles

92103

University of California San Diego Medical Center, San Diego

97227

Legacy Emanuel Hospital & Health Center, Portland

04401

Eastern Maine Medical Center, Bangor

04102

Maine Medical Center, Portland

01199

Baystate Medical Center, Springfield

01655

University of Massachusetts Memorial Medical Center, Worcester

08903

Robert Wood Johnson University Hospital, New Brunswick

Unknown

Hospital Francisco Lopez Lima, General Roca

Hospital de Emergencias Clemente Alvarez (HECA), Rosario

"Hospital Nacional Profesor Alejandro Posadas", Buenos Aires

Hospital Regional De Comodoro Rivadavia (HRCR), Comodoro Rivadavia

Hospital Central de Mendoza, Mendoza

Hospital San Martin, Paraná

Hospital Dr. José Maria Cullen, Santa Fé

Medizinische Universität Graz, Graz

Medizinische Universität Innsbruck, Innsbruck

Unfallkrankenhaus Salzburg, Salzburg

Landesklinikum Wiener Neustadt, Vienna

ULB Erasme, Brussels

Ziekenhuis Oost-Limburg, Location Sint Jan, Genk

Universitair Ziekenhuis Gent, Ghent

University Hospital of the Free University Brussels (UZ Brussel), Jette

University Hospital Gasthuisberg, Leuven

Chengdu Military General Hospital, Chengdu

The First Affiliated Hospital of Fujian Medical University, Fuzhou

The 2nd Affiliated Hospital of Zhejiang University, Hangzhou

The Second Hospital of Shandong University, Jinan

Huashan Hospital of Fudan University, Shanghai

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

General Hospital of Tianjin Medical University, Tianjin

The Affiliated Hospital of Xuzhou Medical College, Xuzhou

Fakultní nemocnice Brno Neurochirurgická klinika, Brno

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

Fakultní Nemocnice Plzeň, Neurochirurgicé Oddĕlení, Pilsen

Fakultní nemocnice Kralovske Vinohrady, Prague

Tampere University Hospital, Tampere

Groupe Hospitalier Pellegrin, Bordeaux

Hôpital Pierre Wertheimer, Bron

Centre Hospitalier Universitaire de Grenoble- Hópital Michallon, La Tronche

CHRU de Lille- Hópital Roger Salengro, Lille

Centre Hospitalier Universitaire de Limoges, Limoges

Centre Hospitalier Universitaire Hôpital Nord, Marseille

Hópital Central - CHU de Nancy, Nancy

Groupe Hospitalier La Salpêtrière, Paris

Charité - Universitätsmedizin Berlin, Berlin

Krankenhaus Merheim, Cologne

Klinikum der J.W. Goethe-Universität, Frankfurt

Universitätsmedizin Göttingen, Göttingen

Berufsgenossenschaftliche Kliniken, Halle

Universitätsklinikum Hamburg-Eppendorf, Hamburg

Universitätsklinikum Heidelberg, Heidelberg

Universitätsklinikum Gießen und Marburg gGmbH, Marburg

Klinikum Nürnberg, Nuremberg

Niels-Stensen-Kliniken, Osnabrück

Universitätsklinikum Ulm, Ulm

Honvédelmi Minisztérium Állami Egészségügyi Központ, Budapest

Pécsi Tudományegyetem Általános Orvostudományi Kar, Pécs

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged

Rambam Medical Center, Haifa

Hadassah Medical Organization, Jerusalem

Rabin Medical Center, Petah Tikva

Tel Aviv Sourasky Medical Center, Tel Aviv

Chaim Sheba Medical Center, Tel Litwinsky

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan

Fondazione San Raffaele del Monte Tabor, Milan

Azienda Ospedaliera San Gerardo, Monza

Azienda Ospedaliero Universitaria Maggiore della Caritá, Novara

Azienda Ospedaliera San Camillo Forlanini, Rome

Azienda Ospedaliero Universitaria Integrata di Verona, Verona

Hospital Raja Permaisuri Bainun, Ipoh

Hospital Kuala Lumpur, Kuala Lumpur

University Malaya Medical Centre, Kuala Lumpur

Hospital Tengku Ampuan Afzan, Kuantan

Sarawak General Hospital, Kuching

VU Medisch Centrum, Amsterdam

Universitair Medisch Centrum Groningen, Groningen

Spitalul Clinic Judetean de Urgenta Timisoara, Timișoara

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

"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

"State Institution Burdenko Neurosurgical Institute of RAMS", Moscow

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

"Saint Petersburg Healthcare Institution City Mariinsky Hospital", Saint Petersburg

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

National Neuroscience Institute, Singapore

National University Hospital, Singapore

Singapore General Hospital, Singapore

Hospital Universitario Germans Trias i Pujol, Badalona

Hospital Parc Taulí, Sabadell

Hospital General Universitario de Alicante, Alicante

Hospital Universitario de Bellvitge, Barcelona

Hospital Universitario Vall Hebrón, Barcelona

Hospital Universitario de Girona Dr. Josep Trueta, Girona

Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitari Son Espases, Palma de Mallorca

Hospital Universitario Virgen del Rocio, Seville

Hospital Clínico Universitario De Valencia, Valencia

Hospital Universitari i Politecnic La Fé de Valencia, Valencia

Taichung Veterans General Hospital, Taichung

National Taiwan University Hospital, Taipei

Chiang Mai University, Chiang Mai

Faculty of Medicine, Prince of Songkla University, Hat Yai

Khon Kaen Hospital, Khon Kaen

Royal Preston Hospital, Fulwood

Queen Elizabeth Hospital, Birmingham

University Hospital Coventry, Coventry

Leeds Teaching Hospitals NHS, Leeds General Infirmary, Leeds

The Royal London Hospital, London

The James Cook University Hospital, Middlesbrough

Southampton University Hospital, Southampton

Sponsors
All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

collaborator

Syneos Health

OTHER

lead

BHR Pharma, LLC

INDUSTRY

NCT01143064 - Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury | Biotech Hunter | Biotech Hunter