Trial Condition(s):

Venous Thromboembolism

Rivaroxaban (10mg) given once daily in patients undergoing Total Hip replacement compared to Enoxaparin

Bayer Identifier:

11354

ClinicalTrials.gov Identifier:

NCT00329628

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.

Inclusion Criteria
- Male and female patients aged 18 years or above
 - Patients scheduled for elective total hip replacement
Exclusion Criteria
- Planned, staged total bilateral hip replacement
 - Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
 - Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
 - Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)

Trial Summary

Enrollment Goal
4541
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
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Kreiskrankenhaus Rheinfelden

Rheinfelden, Germany, 79618

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Sana Kliniken

Sommerfeld, Germany, 16766

Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Locations

Orthopädische Universitätsklinik - Friedrichsheim

Frankfurt, Germany, 60528

Locations

Klinikum Fürth

Fürth, Germany, 90766

Locations

Asklepios Klinik Birkenwerder

Birkenwerder, Germany, 16547

Locations

Center for Joint Care

Missoula, United States, 59802

Locations

Charleston Orthopaedic Associates

Charleston, United States, 29414

Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Locations

Lubbock Sports Medicine

Lubbock, United States, 79410

Locations

Carrell Clinic

Dallas, United States, 75231

Locations

Unlimited Research, LP

San Antonio, United States, 78233

Locations

Texas Orthopedic Specialists

Grapevine, United States, 76051

Locations

Capstone Clinical Trials, Inc.

Birmingham, United States, 35205

Locations

Hôpital de Hautepierre

VANDOEUVRE LES NANCY, France, 54511

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Städtische Kliniken Frankfurt am Main / Hoechst

Frankfurt, Germany, 65929

Locations

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Germany, 82467

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Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

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Klinikum der Philipps-Universität

Marburg, Germany, 35043

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Caritas Krankenhaus GmbH

Bad Mergentheim, Germany, 97980

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Orthopädische Klinik König-Ludwig-Haus

Würzburg, Germany, 97080

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Aukammklinik für operative Rheumatologie

Wiesbaden, Germany, 65191

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Olgahospital

Stuttgart, Germany, 70176

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Universität Rostock - Medizinische Fakultät

Rostock, Germany, 18057

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Universitätsklinikum Heidelberg

Heidelberg, Germany, 69112

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Klinikum Bremen Mitte gGmbH

Bremen, Germany, 28205

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Universität Witten/Herdecke

Witten, Germany, 58448

Locations

West Alabama Research, Inc.

Northport, United States, 35476

Locations

Scripps Center of Orthopaedic Research & Education

La Jolla, United States, 92037

Locations

Institut Montsouris - Paris

PARIS CEDEX 14, France, 75877

Locations

Clinique les Maussins-Nollet - Paris

PARIS CEDEX 19, France, 75019

Locations

Clinique du Cèdre - Bois Guillaume

BOIS-GUILLAUME, France, 76230

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Clinique Océane - Vannes

VANNES, France, 56000

Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

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SP Szpital Kliniczny AM w Bialymstoku

Bialystok, Poland, 15-276

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V Wojskowy Szpital Kliniczny i Poliklinika SPZOZ

Krakow, Poland, 30-901

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Szpital Uniwersytecki im. Antoniego Jurasza

Bydgoszcz, Poland, 85-094

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Szpital Specjalistyczny im. Zeromskiego SPZOZ

Krakow, Poland, 31-913

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Wojewodzki Szpital Brodnowski SPZOZ

Warszawa, Poland, 03-242

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Wojew. Centrum Ortopedii i Rehabilitacji Narz¿du Ruchu

Lodz, Poland, 91-002

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10 Wojskowy Szpital Kliniczny

Bydgoszcz, Poland, 85-681

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AUSL 1 Perugia - Umbria

Gubbio, Italy, 06024

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A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

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A.O. Ospedale Circolo Busto Ar

Busto Arsizio, Italy, 21052

Locations

Atlanta Knee and Sports Medicine

Decatur, United States, 30033

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Colorado Orthopaedic Consultants, PC

Aurora, United States, 80012

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Saline Memorial Hospital

Benton, United States, 72015

Locations

Diaconesses Croix Saint Simon - Paris

PARIS CEDEX 20, France, 75960

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Polyclinique de l'Atlantique - Saint Herblain

SAINT HERBLAIN, France, 44819

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Centre Hospitalier Mignot - Le Chesnay

LE CHESNAY, France, 78150

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Polyclinique de Riaumont - Lievin

LIEVIN, France, 62806

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Centre clinical - Soyaux

SOYAUX, France, 16800

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Nouvelles Cliniques Nantaises - Nantes

NANTES CEDEX 2, France, 44277

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Institut Médical des Sciences et du Sport - Monaco

MONACO, France, 98000

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Cochin - Paris

PARIS, France, 75674

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Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ

Lublin, Poland, 20-718

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Wojewodzki Szpital Specjalistyczny im. Rydygiera

Krakow, Poland, 31-826

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Wojskowy Instytut Medyczny

Warszawa, Poland, 00-909

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A.O.U. Ospedali Riuniti Ancona

Ancona, Italy, 60126

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A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

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A.O.U. di Ferrara

Ferrara, Italy, 44100

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Policlinico Universitario Sassari

Sassari, Italy, 07100

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A.O. Osp Niguarda Ca' Granda

Milano, Italy, 20162

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A.O.U. San Martino

Genova, Italy, 16132

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Complesso Integrato Columbus

Roma, Italy, 00168

Locations

C.T.O. Università degli Studi di Firenze

Firenze, Italy, 50139

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

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Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

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Complejo Hospitalario de Jaén

Jaén, Spain, 23007

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Clínica Universitaria de Navarra

Pamplona, Spain, 31008

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Hospital del Mar

Barcelona, Spain, 08003

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Hospital General de Castelló

Castellón de la Plana, Spain, 12004

Locations

Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen

Warszawa, Poland, 02-005

Locations

SP Szpital Kliniczny nr 1 PAM

Szczecin, Poland, 71-252

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Wielkop. Centrum Ortopedii i Chirurgii Urazowej

Poznan, Poland, 60-703

Locations

Wojewodzki Szpital Specjalistyczny nr 5

Sosnowiec, Poland, 41-200

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SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego

Katowice, Poland, 40-635

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Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Gdansk, Poland, 80-803

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Rehabilitacyjno-Ortopedyczny Zespó¿ Opieki Zdrowotnej

Wroclaw, Poland, 51-128

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Szpital Wojewodzki

Opole, Poland, 45-060

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A.O. San Gerardo di Monza

Monza, Italy, 20052

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IRCCS Ist Clinico Humanitas

Rozzano, Italy, 20089

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IRCCS Ist Ortopedico Rizzoli

Bologna, Italy, 40136

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IRCCS Fondazione San Raffaele

Milano, Italy, 20132

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A.O.U. Policlinico Giaccone

Palermo, Italy, 90129

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AUSL 1 SS Ospedale Marino

Alghero, Italy, 07041

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A.O. CTO-CRF-Maria Adelaide

Torino, Italy, 10126

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Gruppo Ospedaliero San Donato

San Donato Milanese, Italy, 20097

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Clínica Platón

Barcelona, Spain, 08006

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Hospital Dos de Maig - Consorci Sanitari Integral

Barcelona, Spain, 08025

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Hospital General de L'Hospitalet

L'Hospitalet de llobregat, Spain, 08906

Locations

ADA Medical, Ltd.

Oshawa, Canada, L1J 2J2

Locations

Hopital St-Francois d'Assise-CHUQ

Quebec, Canada, G1L 3L5

Locations

Peterborough Regional Health Centre

Peterborough, Canada, K9J 7C6

Locations

Montreal General Hospital

Montreal, Canada, H3G 1A4

Locations

Grand River Hospital

Kitchener, Canada, N2G 1G3

Locations

University of Alberta

Edmonton, Canada, T6G 2B7

Locations

Stratford General Hospital

Stratford, Canada, N5A 2Y6

Locations

UZ Leuven Pellenberg

PELLENBERG, Belgium, 3212

Locations

Jan Palfijn Ziekenhuis

MERKSEM, Belgium, 2170

Locations

AZ St-Jan Brugge

BRUGGE, Belgium, 8000

Locations

AZ Klina

BRASSCHAAT, Belgium, 2930

Locations

Tergooiziekenhuizen Hilversum

HILVERSUM, Netherlands, 1213 XZ

Locations

Spaarne Ziekenhuis

HOOFDDORP, Netherlands, 2134 TM

Locations

Università Cattolica Roma

Roma, Italy, 00168

Locations

A.O. Osp Circolo e Fond.Macchi

Varese, Italy, 21100

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Ciutat Sanitària i Universitaria de la Vall d'Hebrón

Barcelona, Spain, 08035

Locations

Fundación Hospital Alcorcón

Alcorcón, Spain, 28922

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Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

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Hospital Txagorritxu

Vitoria, Spain, 01009

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Hospital Central de Asturias

Oviedo, Spain, 33006

Locations

St. Mary's Hospital Center

Montreal, Canada, H3T 1M5

Locations

Oakville-Trafalgar Memorial Hospital

Oakville, Canada, L6J 3L7

Locations

ZNA Middelheim

ANTWERPEN, Belgium, 2020

Locations

Virga Jesse Ziekenhuis

HASSELT, Belgium, 3500

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Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Locations

Stedelijk Ziekenhuis

ROESELARE, Belgium, 8800

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AZ H. Familie

REET, Belgium, 2840

Locations

CHR de Huy

HUY, Belgium, 4500

Locations

St. Maartenskliniek

NIJMEGEN, Netherlands, 6522 JV

Locations

Diaconessenhuis

LEIDEN, Netherlands, 2334 CK

Locations

Academisch Medisch Centrum Universiteit van Amsterdam

AMSTERDAM, Netherlands, 1105 AZ

Locations

Bernhoven Ziekenhuis

OSS, Netherlands, 5342 BT

Locations

Hospital de Traumatologia y Ortopedia Lomas Verdes IMSS

Edo. de Mexico, Mexico, 53120

Locations

Sjukhuset i Varberg

Varberg, Sweden, 432 81

Locations

Skaraborgs Sjukhus Lidköping

Lidköping, Sweden, 531 85

Locations

Länssjukhuset Ryhov

Jönköping, Sweden, 551 85

Locations

Gentofte Hospital

Hellerup, Denmark, 2900

Locations

Notodden sykehus

Notodden, Norway, NO-3675

Locations

Sykehuset Innlandet HF Gjøvik

Gjövik, Norway, 2819

Locations

Martina Hansens Hospital

Baerum postterminal, Norway, 1306

Locations

Pretoria Academic Hospital Ethics Committee

Pretoria, South Africa, 0084

Locations

Ustredni vojenska nemocnice Praha

Praha 6, Czech Republic, 169 02

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Faculty Hospital Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

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Fakultni nemocnice Plzen

Plzen, Czech Republic, 304 60

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Okresni nemocnice Jindrichuv Hradec

Jindrichuv Hradec, Czech Republic, 377 38

Locations

Nemocnice Ceske Budejovice

Ceske Budejovice, Czech Republic, 370 87

Locations

Isala Klinieken, lokatie Weezenlanden

ZWOLLE, Netherlands, 8011 JW

Locations

Hospital Regional ISSSTE Monterrey

Monterrey, Mexico, 64380

Locations

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64460

Locations

SU/Östra

Göteborg, Sweden, 416 85

Locations

Länssjukhuset

Halmstad, Sweden, 301 85

Locations

Västerviks Sjukhus

Västervik, Sweden, 593 81

Locations

Nordsjællands Hospital - Hørsholm

Hørsholm, Denmark, DK-2970

Locations

Regionshospitalet Silkeborg

Silkeborg, Denmark, 8600

Locations

Herlev Hospital

Herlev, Denmark, 2730

Locations

H:S Frederiksberg Hospital

Frederiksberg, Denmark, 2000

Locations

Sykehuset Innlandet HF Lillehammer

Lillehammer, Norway, 2609

Locations

Sykehuset Innlandet HF Elverum

Elverum, Norway, 2409

Locations

Vergelegen Medi-Clinic

Somerset West, South Africa, 7130

Locations

Clinical Projects Research SA

Worcester, South Africa, 6850

Locations

Oblastni nemocnice Mlada Boleslav

Mlada Boleslav, Czech Republic, 293 50

Locations

Oblastni Nemocnice Pribram

Pribram I, Czech Republic, 261 26

Locations

Nemocnice Prostejov

Prostejov, Czech Republic, 796 04

Locations

Rambam Medical Center

Haifa, Israel, 31096

Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 49100

Locations

Eastern Clinical Research Unit - Box Hill

Melbourne, Australia, 3128

Locations

St George Hospital

Sydney, Australia, 2217

Locations

Fremantle Hospital

Fremantle, Australia, 6160

Locations

Hospital Municipal de Berazatequi Evita Pueblo

Berazategui, Argentina, 1884

Locations

Hospital Alvarez

Buenos Aires, Argentina, C1406FWY

Locations

Sanatorio Mitre

Buenos Aires, Argentina, C1039AAO

Locations

Sanatorio Regional UOM Avellaneda

Avellaneda, Argentina, 1870

Locations

Hospital Fernández

Buenos Aires, Argentina, C1425AGP

Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Locations

Allgem. öffentl. Krankenhaus Wiener Neustadt

Wiener Neustadt, Austria, 2700

Locations

A.ö. Krankenhaus der Stadt Linz

Linz, Austria, 4020

Locations

KH d. Barmherzigen Schwestern Ried Betriebsges.m.b.H.

Ried, Austria, 4910

Locations

Hospital Karlovy Vary

Karlovy Vary, Czech Republic, 360 66

Locations

Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 775 20

Locations

Assaf Harofeh Medical Center

Zerifin, Israel, 70300

Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Locations

Sapir Medical Center, Meir General Hospital

Kfar Saba, Israel, 44281

Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Locations

Soroka University Medical Center

Beer Sheva, Israel, 84101

Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 52621

Locations

The Avenue Cardiovascular Centre

Melbourne, Australia, 3181

Locations

Flinders Medical Centre

Adelaide, Australia, 5042

Locations

Hospital Británico

Buenos Aires, Argentina, C1280AEB

Locations

Hospital Militar Central "CIR. MY. C. Argerich"

Buenos Aires, Argentina, 1426

Locations

Medizinische Universität Graz

Graz, Austria, 8036

Locations

SMZ Baumgartner Höhe Otto Wagner Spital

Wien, Austria, 1140

Locations

Klinikum Kreuzschwestern Wels GmbH

Wels, Austria, 4600

Locations

Hospital San José

Santiago, Chile

Locations

Hospital del Trabajador de Santiago

Santiago, Chile

Locations

Petz Aladar Megyei Korhaz

Györ, Hungary, 9024

Locations

Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, Hungary, 1076

Locations

Tolna County Hospital

Szekszard, Hungary, 7100

Locations

Dokuz Eylul Universitesi

Izmir, Turkey, 35340

Locations

Istanbul Univ. Medical Faculty

Istanbul, Turkey, 34093

Locations

Attikon University General Hospital of Attica

Haidari, Greece, 12462

Locations

KAT General Hospital of Athens

Kifisia, Greece, 14561

Locations

Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, Brazil, 04039-004

Locations

Hospital de Traumáto-Ortopedia - INTO

Rio de Janeiro, Brazil, 20 232 092

Locations

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90470 340

Locations

Pontificia Universidade Católica - Centro Clínico

Porto Alegre, Brazil, 90610-000

Locations

Kaunas Medical University Hospital

Kaunas, Lithuania, LT-50166

Locations

Mikkelin keskussairaala

Mikkeli, Finland, FIN-50100

Locations

Seinäjoen keskussairaala

Seinäjoki, Finland, FIN 60220

Locations

Krankenhaus der Barmherzigen Schwestern Linz

Linz, Austria, 4010

Locations

Szeged University Medical School

Szeged, Hungary, 6725

Locations

Bacs-Kiskun Country Hospital

Kecskemet, Hungary, 6000

Locations

Fejer megyei Szent Gyorgy Korhaz

Szekesfehervar, Hungary, 8000

Locations

Bekes County Hospital "Rethy Pal"

Bekescsaba, Hungary, 5600

Locations

Somogy County Hospital "Kaposi Mor"

Kaposvar, Hungary, 7400

Locations

University of Semmelweis

Budapest, Hungary, 1089

Locations

MoH Goztepe Trainning Hospital

Istanbul, Turkey, 34722

Locations

Marmara University Medical Faculty

Istanbul, Turkey, 34662

Locations

Cukurova Universitesi Tip Fakultesi Hastanesi

Adana, Turkey, 01330

Locations

Centro de Investigación Clínica FOQUS

Bogotá, Colombia

Locations

Fundación Cardioinfantil

Bogotá, Colombia

Locations

Cosultorio Privado Dr. Toledo

Bogotá, Colombia

Locations

Fakultna nemocnica s poliklinikou

Bratislava, Slovakia, 826 06

Locations

Nemocnica s poliklinikou Zilina

Zilina, Slovakia, 012 07

Locations

Nemocnica Kosice-Saca

Kosice - Saca, Slovakia, 040 15

Locations

Vilnius University Hospital of Emergency Care

Vilnius, Lithuania, LT-04130

Locations

Keski-Suomen keskussairaala

Jyväskylä, Finland, 40620

Trial Design