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Completed

NCT Number: NCT03068923

Thrombosis Outcomes in Pediatric Venous Thromboembolism

'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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Medical Center

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Symptomatic recurrent venous thromboembolism

    Time frame: within 24 months after diagnosis of VTE

    Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria

  3. 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)

Secondary outcomes

  1. 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

  2. Change in quality of life

    Time frame: Within 24 months after diagnosis of VTE

    Quality of life by PedsQL (TM)

Other outcomes

  1. Change in Physical Activity scores

    Time frame: Within 24 months after diagnosis of VTE

    Physical activity as determined by Gordin questionnaire

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children

Acronym: TOP

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2017
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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