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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL132054-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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'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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Postthrombotic syndrome (PTS) | PTS as assessed by the validated Manco-Johnson and the modified Villata PTS instruments determined a priori and confirmed by an endpoint adjudicating committee | within 24 months after diagnosis of VTE |
| Symptomatic recurrent venous thromboembolism | Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria | within 24 months after diagnosis of VTE |
| Post-pulmonary embolism (PE) impairment | 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) | within 24 months after diagnosis of VTE |
| Measure | Description | Time Frame |
|---|---|---|
| Post-thrombotic sequelae | Site specific sequelae after cerebral sinus venous, portal vein and renal vein thrombosis as assessed by ISTH recommended guidelines | Within 24 months after diagnosis of VTE |
| Change in quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity scores | Physical activity as determined by Gordin questionnaire | Within 24 months after diagnosis of VTE |
| Elastic Compression Stocking (ECS) use over time | 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) |
Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed patients with first venous thromboembolism who have completed therapeutic anticoagulant therapy
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| Name | Affiliation | Role |
|---|---|---|
| Ayesha Zia, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29078111 | Result | 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. |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Plasma and DNA samples
Quality of life by PedsQL (TM)
| Within 24 months after diagnosis of VTE |
| Within 24 months after diagnosis of VTE |
| Loss of venous access | 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 | 12 months post DVT diagnosis |
| Venous valvular reflux | 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 | 12 months post DVT diagnosis |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |