CompletedNot Applicable

Thrombosis Outcomes in Pediatric Venous Thromboembolism

United States120 participantsStarted 2016-05

Plain-language summary

'The TOP Study' is a prospective cohort study whose main objective is to develop better prognostic biomarkers and identify children at risk of adverse thrombotic outcomes very early in the course after an initial venous thromboembolic events (VTE). The study will compare biomarkers in children that develop poor VTE outcomes (such as recurrence, postthrombotic syndrome and post PE impairment ) after an initial VTE with those that do not develop such outcomes.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Boys and girls age birth (0 years) to equal to or less than 21 years * A radiologically confirmed first venous thromboembolism episode (both extremity and non-extremity) who have completed anticoagulation therapy as per the 9th edition of the ACCP guidelines Exclusion Criteria: * Known malignancy * Pregnancy or immediate post-partum period (12 weeks after delivery) * Sickle cell disease * Known bleeding disorder

What they're measuring

Postthrombotic syndrome (PTS)

Timeframe: within 24 months after diagnosis of VTE

Symptomatic recurrent venous thromboembolism

Timeframe: within 24 months after diagnosis of VTE

Post-pulmonary embolism (PE) impairment

Timeframe: within 24 months after diagnosis of VTE

Trial details

NCT IDNCT03068923

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-09

View on ClinicalTrials.gov More Venous Thromboembolism trials