Venous ThromboembolismTOPNCT03068923
Thrombosis Outcomes in Pediatric Venous Thromboembolism
An observational study of Venous Thromboembolism, run by University of Texas Southwestern Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 9 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Newly diagnosed patients with first venous thromboembolism who have completed therapeutic anticoagulant therapy
Who may be able to join
- 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
Who cannot join
- Known malignancy
- Pregnancy or immediate post-partum period (12 weeks after delivery)
- Sickle cell disease
- Known bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children
'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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Keywords
- Blood clot, Deep Vein Thrombosis, Pulmonary Embolism, Lower Extremity, Upper Extremity, Cerebral sinus, Renal vein, Portal vein, thrombin, fibrinolysis, coagulation, anticoagulation, Post trombotic syndrome, Post pulmonary embolism syndrome, Chronic thromboembolic pulmonary hypertension
- Medical subject headings
- Venous Thromboembolism, Thrombosis, Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 24 months after diagnosis of VTE
Symptomatic recurrent venous thromboembolism
Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria
Measured: 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)
Measured: within 24 months after diagnosis of VTE
Secondary outcomes (2)
Post-thrombotic sequelae
Site specific sequelae after cerebral sinus venous, portal vein and renal vein thrombosis as assessed by ISTH recommended guidelines
Measured: Within 24 months after diagnosis of VTE
Change in quality of life
Quality of life by PedsQL (TM)
Measured: Within 24 months after diagnosis of VTE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startMay 2016
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ayesha Zia, University of Texas Southwestern Medical Center
- Investigators
- Ayesha Zia, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068923
- Sponsor's protocol ID
- STU 122015-029
- Other IDs
- 1K23HL132054-01
- Acronym
- TOP
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2017
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29078111
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting and Preventing Poor Outcomes of Venous Thromboembolism in Children
- ClinicalTrials.gov ID
- NCT03068923
- Acronym / sponsor ID
- TOP / STU 122015-029
- Conditions
- Venous Thromboembolism
- Keywords
- Blood clot, Deep Vein Thrombosis, Pulmonary Embolism, Lower Extremity, Upper Extremity, Cerebral sinus, Renal vein, Portal vein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2016 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Newly diagnosed patients with first venous thromboembolism who have completed therapeutic anticoagulant therapy
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Known malignancy
- Pregnancy or immediate post-partum period (12 weeks after delivery)
- Sickle cell disease
- Known bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Symptomatic recurrent venous thromboembolism
Time frame: within 24 months after diagnosis of VTE
Recurrent VTE as assessed by ISTH proposed recurrent VTE clinical criteria
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)
2 secondary outcomes
Post-thrombotic sequelae
Time frame: Within 24 months after diagnosis of VTE
Change in quality of life
Time frame: Within 24 months after diagnosis of VTE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Results publication: PubMed 29078111Zia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Zia, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postthrombotic syndrome (PTS) (time frame: within 24 months after diagnosis of VTE). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.