NCT03068923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

5.9 years

First QC Date

February 22, 2017

Last Update Submit

January 28, 2025

Conditions

Venous Thromboembolism

Keywords

Blood clotDeep Vein ThrombosisPulmonary EmbolismLower ExtremityUpper ExtremityCerebral sinusRenal veinPortal veinthrombinfibrinolysiscoagulationanticoagulationPost trombotic syndromePost pulmonary embolism syndromeChronic thromboembolic pulmonary hypertension

Outcome Measures

Primary Outcomes (3)

  • 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

  • Symptomatic recurrent venous thromboembolism

    Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria

    within 24 months after diagnosis of VTE

  • 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 Outcomes (2)

  • Post-thrombotic sequelae

    Within 24 months after diagnosis of VTE

  • Change in quality of life

    Within 24 months after diagnosis of VTE

Other Outcomes (4)

  • Change in Physical Activity scores

    Within 24 months after diagnosis of VTE

  • Elastic Compression Stocking (ECS) use over time

    Within 24 months after diagnosis of VTE

  • Loss of venous access

    12 months post DVT diagnosis

  • +1 more other outcomes

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related 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-analysis. Thromb Res. 2017 Dec;160:1-8. doi: 10.1016/j.thromres.2017.10.003. Epub 2017 Oct 7.

    PMID: 29078111RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and DNA samples

MeSH Terms

Conditions

Venous ThromboembolismThrombosisVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Ayesha Zia, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 3, 2017

Study Start

May 1, 2016

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)