Thrombosis Outcomes in Pediatric Venous Thromboembolism

Venous Thromboembolism Clinical Trial

— TOP  

Official title:

Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03068923
• Other study ID #: STU 122015-029
• Secondary ID: 1K23HL132054-01
• Status: Active, not recruiting
• Start date: May 2016
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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-analys — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Physical Activity scores	Physical activity as determined by Gordin questionnaire	Within 24 months after diagnosis of VTE
Other	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)	Within 24 months after diagnosis of VTE
Other	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
Other	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
Primary	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
Primary	Symptomatic recurrent venous thromboembolism	Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria	within 24 months after diagnosis of VTE
Primary	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
Secondary	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
Secondary	Change in quality of life	Quality of life by PedsQL (TM)	Within 24 months after diagnosis of VTE