Thrombosis Outcomes in Pediatric Venous Thromboembolism (TOP)

The University of Texas System (UT)

Status: Completed

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03068923

STU 122015-029

1K23HL132054-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

'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.

Full description

All newly diagnosed patients with a first radiologically confirmed thrombotic event (any site) diagnosed at Children's Medical Center, Dallas will be followed prospectively with global coagulation assessment over a 24-month period, and monitored for development of carefully defined adverse VTE outcomes in a blinded manner. Biomarker assessment will include global coagulation assays (thrombin generation assay and modified thromboelastography to study fibrinolysis) at 3, 6, 12, 18 and 24 months post VTE diagnosis.

Enrollment: 120 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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