267
Participants
Start Date
September 25, 2013
Primary Completion Date
October 16, 2019
Study Completion Date
November 14, 2019
dabigatran etexilate
Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation
standard of care
Low molecular weight heparin, vitamin K antagonist or fondaparinux prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)
Taichung Veterans General Hospital, Taichung
AKH - Medical University of Vienna, Vienna
Brussels - UNIV Saint-Luc, Brussels
Cukurova Universitesi Tip Fakultesi Cocuk Sagligi, Adana
Rigshospitalet, København, Børneonkologisk Afsnit 5002, Copenhagen
UZ Leuven, Leuven
University Debrecen Hospital, Debrecen
Medical University of Innsbruck, Innsbruck
Akdeniz Universitesi Tip Fakultesi, Antalya
Universitäts-Kinderspital, Zurich
UNIV UZ Gent, Ghent
Ospedale Infantile Regina Margherita, Torino
King Chulalongkorn Memorial Hospital, Bangkok
"Aghia Sophia Children's Hospital", Athens
University Hospital Motol, Prague
Reg.Children Hosp,Vinnytsia, Vinnytsia
University of Virginia Health System, Charlottesville
Wake Forest University Health Sciences, Winston-Salem
Hospital Infantil Universitario Niño Jesus, Madrid
HOP de la Cavale Blanche, Brest
University of Miami, Miami
TaUH, Pediatric Early Phase Trial Unit, Tampere
St. Joseph's Children's Hospital, Tampa
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul
Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH, Istanbul
Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali, Izmir
Sahlgrenska US, Göteborg, Gothenburg
Necmettin Erbakan Universitesi Meram Tip Fakultesi, Konya
Universitätsklinikum Essen AöR, Essen
Universitätsklinikum Münster, Münster
Reg.Children Hosp.Dnipropetrovsk, Dnipropetrovsk
Blank Children's Hospital, Des Moines
University of Iowa Hospitals and Clinics, Iowa City
University Hospital Brno, Brno
Hospital Universitario Dr Jose Eleuterio Gonzalez, Nuevo León
University Hospital Ostrava, Ostrava
University Hospital Olomouc, Olomouc
University of California Davis, Sacramento
Providence Sacred Heart Medical Center and Children's Hospital, Spokane
Izmilovskaya Child City ClinHosp,Haematological Dept, Moscow, Moscow
Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol, Moscow
St.Petersburg State Pediatric Univ.Ministry of Healthcare RF, Saint Petersburg
Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan, Kazan'
Childr.CityClin.Hos#9,pediatric&Neonatal Neurol.Ekaterinburg, Yekaterinburg
Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery, Tyument
Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo, Kemerovo
Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem
Boston Children's Hospital, Boston
Hospital General de Niños Pedro de Elizalde, CABA
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas, Campinas
Faculdade de Ciencias Medicas da UNICAMP, Campinas
PenSI - Pesquisa e Ensino em Saude Infantil, São Paulo
Instituto de Crianca / Hospital das Clínicas-FMUSP, São Paulo
Children's Hospital of Eastern Ontario, Ottawa
The Hospital for Sick Children, Toronto
CHU Sainte-Justine, Montreal
General Univ.hosp Hradec Kralove, Hradec Králové
University Hospital Plzen, Plzen-Lochotin, Plzen-Lochotin
"Università degli Studi La Sapienza", Roma
Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius, Vilnius
Instituto Nacional de Pediatría, México D.F
Haukeland Universitetssykehus, Bergen
Oslo Universitetssykehus HF, Rikshospitalet, Oslo
Karolinska Univ. sjukhuset, Solna
Hacettepe Universitesi Tip Fakultesi, Ankara
Lead Sponsor
Boehringer Ingelheim
INDUSTRY