Thrombosis Outcomes in Pediatric Venous Thromboembolism
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 8/24/2018 |
| Start Date: | May 2016 |
| End Date: | April 2021 |
| Contact: | Kendra Malone, MPH |
| Email: | kendra.malone@childrens.com |
| Phone: | 214-456-3359 |
Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children
'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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
