Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
- Conditions
- Secondary PreventionVenous Thromboembolism
- Interventions
- Registration Number
- NCT02197416
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dabigatran etexilate dabigatran etexilate -
- Primary Outcome Measures
Name Time Method Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months At month 6 (Week 26) and 12 (Week 52) of on treatment period The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months At month 6 (Week 26) and month 12 (Week 52) of on treatment period The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months At month 6 (Week 26) and 12 (Week 52) of on treatment period The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months.
Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
- Secondary Outcome Measures
Name Time Method Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months At month 6 (Week 26) and 12 (Week 52) of on treatment period The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 days Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) At Visit 3 (day 4 after first dose of trial medication) Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days. Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) At Visit 3 (day 4 after first dose of trial medication) Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days. Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses) At Visit 3 (day 4 after first dose of trial medication) Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment) dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.
Trial Locations
- Locations (62)
University of Miami
🇺🇸Miami, Florida, United States
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius
🇱🇹Vilnius, Lithuania
Haukeland Universitetssykehus
🇳🇴Bergen, Norway
Universitäts-Kinderspital
🇨🇭Zürich, Switzerland
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP
🇧🇷Sao Paulo, Brazil
Reg.Children Hosp,Vinnytsia
🇺🇦Vinnytsya, Ukraine
Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan
🇷🇺Kazan, Russian Federation
Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo
🇷🇺Kemerovo, Russian Federation
Morozovskaya Children Clin.Hosp.,Haematological Dept, Moscow
🇷🇺Moscow, Russian Federation
Faculdade de Ciencias Medicas da UNICAMP
🇧🇷Campinas, Brazil
Akdeniz Universitesi Tip Fakultesi
🇹🇷Antalya, Turkey
Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH
🇹🇷Istanbul, Turkey
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Brussels - UNIV UZ Brussel
🇧🇪Brussel, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
University Hospital Plzen, Plzen-Lochotin
🇨🇿Plzen - Lochotin, Czechia
Oslo Universitetssykehus HF, Rikshospitalet
🇳🇴Oslo, Norway
UNIV UZ Gent
🇧🇪Gent, Belgium
Cukurova Universitesi Tip Fakultesi Cocuk Sagligi
🇹🇷Adana, Turkey
Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery
🇷🇺Tyument, Russian Federation
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
🇧🇷Campinas, Brazil
University Hospital Motol
🇨🇿Prague, Czechia
HOP Timone
🇫🇷Marseille, France
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi
🇹🇷Konya, Turkey
Reg.Children Hosp.Dnipropetrovsk
🇺🇦Dnipropetrovsk, Ukraine
Ospedale Infantile Regina Margherita
🇮🇹Torino, Italy
Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali
🇹🇷Izmir, Turkey
University of California Davis
🇺🇸Sacramento, California, United States
St. Joseph's Children's Hospital
🇺🇸Tampa, Florida, United States
Alliance for Childhood Diseases
🇺🇸Las Vegas, Nevada, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
🇩🇪Göttingen, Germany
Università degli Studi "La Sapienza"
🇮🇹Roma, Italy
Osp. Pediatrico Bambin Gesù
🇮🇹Roma, Italy
A.O. Univ. Policlinico "Paolo Giaccone"
🇮🇹Palermo, Italy
Childr.CityClin.Hos#9,pediatric&Neonatal Neurol.Ekaterinburg
🇷🇺Yekaterinburg, Russian Federation
St.Petersburg State Pediatric Univ.Ministry of Healthcare RF
🇷🇺St. Petersburg, Russian Federation
Karolinska Univ. sjukhuset
🇸🇪Solna, Sweden
Istanbul Universitesi Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Western Ukrainian Spec.Children Med.Center,Lviv
🇺🇦Lviv, Ukraine
University Hospital Brno
🇨🇿Brno, Czechia
Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol
🇷🇺Moscow, Russian Federation
University Hospital Ostrava
🇨🇿Ostrava, Czechia
Universitätsklinikum Essen AöR
🇩🇪Essen, Germany
CHU Sainte-Justine
🇨🇦Montreal, Ontario, Canada
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Rigshospitalet, København, Børneonkologisk Afsnit 5002
🇩🇰Copenhagen, Denmark
University Debrecen Hospital
🇭🇺Debrecen, Hungary
Shaare Zedek Medical Center, Jerusalem 91031
🇮🇱Jerusalem, Israel
State Budget Healthcare Institution "Republican children's clinical hospital"
🇷🇺Ufa, Russian Federation
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Instituto Nacional de Pediatría
🇲🇽Mexico DF, Mexico
AKH - Medical University of Vienna
🇦🇹Wien, Austria