Clinical trial NCT03068923: Thrombosis Outcomes in Pediatric Venous Thromboembolism
Official title: Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Blood clot
Deep Vein Thrombosis
Pulmonary Embolism
Lower Extremity
Upper Extremity
Cerebral sinus
Renal vein
Portal vein
thrombin
fibrinolysis
coagulation
anticoagulation
Post trombotic syndrome
Post pulmonary embolism syndrome
Chronic thromboembolic pulmonary hypertension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-03
Enrollment: 120
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with first venous thromboembolism who have completed therapeutic anticoagulant therapy

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postthrombotic syndrome (PTS)
timeFrame: within 24 months after diagnosis of VTE
measure: Symptomatic recurrent venous thromboembolism
timeFrame: within 24 months after diagnosis of VTE
measure: Post-pulmonary embolism (PE) impairment
timeFrame: within 24 months after diagnosis of VTE
Secondary outcomes:
measure: Post-thrombotic sequelae
timeFrame: Within 24 months after diagnosis of VTE
measure: Change in quality of life
timeFrame: Within 24 months after diagnosis of VTE
Other outcomes:
measure: Change in Physical Activity scores
timeFrame: Within 24 months after diagnosis of VTE
measure: Elastic Compression Stocking (ECS) use over time
timeFrame: Within 24 months after diagnosis of VTE
measure: Loss of venous access
timeFrame: 12 months post DVT diagnosis
measure: Venous valvular reflux
timeFrame: 12 months post DVT diagnosis
Locations:
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Ayesha Zia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zia A, Russell J, Sarode R, Veeram SR, Josephs S, Malone K, Zhang S, Journeycake J. Markers of coagulation activation, inflammation and fibrinolysis as predictors of poor outcomes after pediatric venous thromboembolism: A systematic review and meta-analysis. Thromb Res. 2017 Dec;160:1-8. doi: 10.1016/j.thromres.2017.10.003. Epub 2017 Oct 7.