A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot

Boehringer Ingelheim6 enrolled

Overview

The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Venous Thromboembolism

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation * Written informed consent from parents/care givers and patient assent if age appropriate * Initiation of Pradaxa Pellets administration either as initial or subsequent therapy: * Treatment of VTE * Treatment to reduce the risk of recurrence of VTE Exclusion Criteria: * Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion * Any contraindications to Pradaxa Pellets according to the US Prescribing Information. * Previous participation in this study.

Locations (10)

University of California, San Diego

La Jolla, California, United States

Rady Children's Hospital

San Diego, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Cumulative incidence of clinically relevant bleeding events

Time frame: Up to week 52

Secondary Outcomes

Occurrence of recurrent Venous Thromboembolic Event (VTE)

Time frame: Up to week 52

Mortality related to thrombotic or thromboembolic events

Time frame: Up to week 52

Occurence of all bleeding events

Time frame: Up to week 52

Occurrence of post-thrombotic syndrome (PTS)

Time frame: Up to week 52

Incidence of adverse events (AEs)

Time frame: Up to week 52

Incidence of serious adverse events (SAEs)

Time frame: Up to week 52

Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease)

Time frame: Baseline and up to week 12

Recurrence of VTE while on treatment

Time frame: Up to week 52

Duration of treatment with dabigatran etexilate

Time frame: Up to week 52

Compliance with dabigatran etexilate treatment

Time frame: Up to week 52

Data from ClinicalTrials.gov

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