Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

PHASE3CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

September 29, 2014

Primary Completion Date

October 16, 2019

Study Completion Date

November 19, 2019

Conditions
Venous ThromboembolismSecondary Prevention
Interventions
DRUG

dabigatran etexilate

Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation

Trial Locations (62)

407

Taichung Veterans General Hospital, Taichung

1090

AKH - Medical University of Vienna, Vienna

Brussels - UNIV UZ Brussel, Brussels

1330

Cukurova Universitesi Tip Fakultesi Cocuk Sagligi, Adana

2100

Rigshospitalet, København, Børneonkologisk Afsnit 5002, Copenhagen

3000

UZ Leuven, Leuven

4032

University Debrecen Hospital, Debrecen

7058

Akdeniz Universitesi Tip Fakultesi, Antalya

8032

Universitäts-Kinderspital, Zurich

9000

UNIV UZ Gent, Ghent

10126

Ospedale Infantile Regina Margherita, Torino

10330

King Chulalongkorn Memorial Hospital, Bangkok

13005

HOP Timone, Marseille

15006

University Hospital Motol, Prague

21029

Reg.Children Hosp,Vinnytsia, Vinnytsia

22908

University of Virginia Health System, Charlottesville

27157

Wake Forest University Health Sciences, Winston-Salem

33136

University of Miami, Miami

33607

St. Joseph's Children's Hospital, Tampa

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

34303

Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH, Istanbul

35040

Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali, Izmir

37075

Universitätsmedizin Göttingen, Georg-August-Universität, Göttingen

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi, Konya

45147

Universitätsklinikum Essen AöR, Essen

48149

Universitätsklinikum Münster, Münster

49100

Reg.Children Hosp.Dnipropetrovsk, Dnipropetrovsk

61300

University Hospital Brno, Brno

70852

University Hospital Ostrava, Ostrava

77900

University Hospital Olomouc, Olomouc

79035

Western Ukrainian Spec.Children Med.Center,Lviv, Lviv

89135

Alliance for Childhood Diseases, Las Vegas

90127

"A.O. Univ. Policlinico Paolo Giaccone", Palermo

95817

University of California Davis, Sacramento

99204

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

119049

Morozovskaya Children Clin.Hosp.,Haematological Dept, Moscow, Moscow

125373

Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol, Moscow

194100

St.Petersburg State Pediatric Univ.Ministry of Healthcare RF, Saint Petersburg

420138

Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan, Kazan'

450106

"State Budget Healthcare Institution Republican children's clinical hospital", Ufa

620134

Childr.CityClin.Hos#9,pediatric&Neonatal Neurol.Ekaterinburg, Yekaterinburg

625023

Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery, Tyument

650002

Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo, Kemerovo

9103102

Shaare Zedek Medical Center, Jerusalem 91031, Jerusalem

13083970

Faculdade de Ciencias Medicas da UNICAMP, Campinas

52242-1083

University of Iowa Hospitals and Clinics, Iowa City

02115

Boston Children's Hospital, Boston

13059-740

HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas, Campinas

04039-001

Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP, São Paulo

K7L 2V7

Kingston General Hospital, Kingston

H3T 1C5

CHU Sainte-Justine, Montreal

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital for Sick Children, Toronto

304 60

University Hospital Plzen, Plzen-Lochotin, Plzen - Lochotin

00161

"Università degli Studi La Sapienza", Roma

00165

Osp. Pediatrico Bambin Gesù, Roma

08406

Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius, Vilnius

04530

Instituto Nacional de Pediatría, Mexico City

N-5021

Haukeland Universitetssykehus, Bergen

N-0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

171 65

Karolinska Univ. sjukhuset, Solna

06100

Hacettepe Universitesi Tip Fakultesi, Ankara

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY