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

a study on Venous Thromboembolism Blood Clot

Summary

Eligibility
for people ages 3 months to 12 years (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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.

Official Title

Safety and Effectiveness of Pradaxa Oral Pellet Formulation for Treatment of Acute Venous Thromboembolic Events (VTE) and/or for Risk Reduction of Recurrence of VTE in Pediatric Patients Aged 3 Months to Less Than 12 Years in a Real World Setting: a Prospective Non-interventional Study Conducted in the United States

Keywords

Venous Thromboembolism, Thromboembolism

Eligibility

You can join if…

Open to people ages 3 months to 12 years

  • Written informed consent from parents/care givers and patient assent if age appropriate
  • Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:

You CAN'T join if...

  • 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

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • Rady Children's Hospital accepting new patients
    San Diego California 92123 United States
  • Cincinnati Children's Hospital accepting new patients
    Cincinnati Ohio 45229 United States
  • Dayton Children's Hospital accepting new patients
    Dayton Ohio 45404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
Links
Related Info
ID
NCT05966740
Study Type
Observational
Participants
Expecting 330 study participants
Last Updated