Thrombosis Outcomes in Pediatric Venous Thromboembolism (TOP)
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ClinicalTrials.gov Identifier: NCT03068923 |
Recruitment Status :
Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : May 19, 2020
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Condition or disease |
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Venous Thromboembolism |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children |
Actual Study Start Date : | May 2016 |
Estimated Primary Completion Date : | February 2022 |
Estimated Study Completion Date : | February 2023 |

- Postthrombotic syndrome (PTS) [ Time Frame: 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
- Symptomatic recurrent venous thromboembolism [ Time Frame: within 24 months after diagnosis of VTE ]Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria
- Post-pulmonary embolism (PE) impairment [ Time Frame: 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)
- Post-thrombotic sequelae [ Time Frame: 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 [ Time Frame: Within 24 months after diagnosis of VTE ]Quality of life by PedsQL (TM)
- Change in Physical Activity scores [ Time Frame: Within 24 months after diagnosis of VTE ]Physical activity as determined by Gordin questionnaire
- Elastic Compression Stocking (ECS) use over time [ Time Frame: 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)
- Loss of venous access [ Time Frame: 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
- Venous valvular reflux [ Time Frame: 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
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068923
United States, Texas | |
Children's Medical Center | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Ayesha Zia, M.D. | University of Texas Southwestern Medical Center |
Responsible Party: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT03068923 |
Other Study ID Numbers: |
STU 122015-029 1K23HL132054-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 3, 2017 Key Record Dates |
Last Update Posted: | May 19, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |