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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 : June 6, 2022
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ayesha Zia, 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.

Condition or disease
Venous Thromboembolism

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.

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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 : May 2023
Estimated Study Completion Date : May 2023

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Biospecimen Retention:   Samples With DNA
Plasma and DNA samples

Information from the National Library of Medicine

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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
Study Population
Newly diagnosed patients with first venous thromboembolism who have completed therapeutic anticoagulant therapy

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

Information from the National Library of Medicine

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

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United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Ayesha Zia, M.D. University of Texas Southwestern Medical Center
Publications of Results:
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Responsible Party: Ayesha Zia, Associate Professor of Pediatrics, 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: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayesha Zia, University of Texas Southwestern Medical Center:
Blood clot
Deep Vein Thrombosis
Pulmonary Embolism
Lower Extremity
Upper Extremity
Cerebral sinus
Renal vein
Portal vein
Post trombotic syndrome
Post pulmonary embolism syndrome
Chronic thromboembolic pulmonary hypertension
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases