Venous Thromboembolism
Conditions
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
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.
Interventions
None listed
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Texas Southwestern Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postthrombotic syndrome (PTS) | within 24 months after diagnosis of VTE | PTS as assessed by the validated Manco-Johnson and the modified Villata PTS instruments determined a priori and confirmed by an endpoint adjudicating committee |
| Post-pulmonary embolism (PE) impairment | within 24 months after diagnosis of VTE | Post-PE impairment, defined as deterioration (compared to discharge or previous follow-up visit), or persistence, in a) echocardiographic parameters of right ventricular (RV) dysfunction (defined by abnormal RV basal diameter or abnormal right atrial end systolic area or abnormal tricuspid annular plane systolic excursion or presence of pericardial effusion) and/or pulmonary hypertension (defined by abnormal estimated right atrial pressure or elevated systolic tricuspid regurgitant velocity), and clinical, functional parameters of RV failure (new appearance of symptoms of heart failure or abnormal six-minute walking distance or elevated brain natriuretic peptide (BNP) plasma levels or abnormal peak O2 uptake on cardiopulmonary exercise testing) |
| Symptomatic recurrent venous thromboembolism | within 24 months after diagnosis of VTE | Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-thrombotic sequelae | Within 24 months after diagnosis of VTE | Site specific sequelae after cerebral sinus venous, portal vein and renal vein thrombosis as assessed by ISTH recommended guidelines |
| Change in quality of life | Within 24 months after diagnosis of VTE | Quality of life by PedsQL (TM) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Elastic Compression Stocking (ECS) use over time | Within 24 months after diagnosis of VTE | ECS use will be assessed by ECS log/diary documenting dedicated (use for at least 6 days/week), moderate (use for 4-5 days/week) or poor use (\<4 days/week) |
| Venous valvular reflux | 12 months post DVT diagnosis | Venous valvular reflux in subjects with lower extremity DVT will be assessed as present (\>0.5 seconds) or absent (\<0.5 seconds) at the 12 month post diagnosis visit with a standardized venous reflux ultrasound procedure |
| Loss of venous access | 12 months post DVT diagnosis | Loss of venous access in subjects with catheter related DVT of the upper extremity DVT as defined by \>30% of the narrowing of the involved vein as assessed by doppler ultrasound or contrast venography |
| Change in Physical Activity scores | Within 24 months after diagnosis of VTE | Physical activity as determined by Gordin questionnaire |
Countries
United States
Outcome results
None listed