Thrombosis Outcomes in Pediatric Venous Thromboembolism

Active, not recruiting

• Conditions: Venous Thromboembolism

• Registration Number: NCT03068923
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• Known malignancy
• Pregnancy or immediate post-partum period (12 weeks after delivery)
• Sickle cell disease
• Known bleeding disorder

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic recurrent venous thromboembolism	within 24 months after diagnosis of VTE	Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria
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)
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

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	Within 24 months after diagnosis of VTE	Quality of life by PedsQL (TM)
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

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States