PROSPECTIVE MULTI-CENTER EVALUATION OF THE DURATION OF THERAPY FOR THROMBOSIS IN CHILDREN (the "Kids-DOTT" Trial)
Studying Treatment Time for Blood Clots in Children
Brief description of study.
This study plans to learn more about the best type of treatment for children with blood clots in the veins.
Detailed description of study
This study is being done to find out how long to treat blood clots in a vein by best balancing the risks of bleeding versus clotting again. The study involves using the follow-up pictures (scans) of the clot, performed as part of the subject's standard care after the initial treatment of a clot, to help determine the total length of treatment needed. Another part of this study involves learning whether different blood thinning medicines affect long-term outcomes from the subject's clot. The type of blood thinner they receive will be determined by their doctor. This study does not determine the type of blood thinner – only the amount of time they receive it.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Thrombosis
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Age: 20 years or below
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Gender: All
Inclusion Criteria
(1) Children (birth to <21 years of age) with radiologically-confirmed acute venous thrombosis in the past 30 days
(2) In the opinion of the investigator, the venous thrombosis was a provoked (i.e., non-spontaneous) event (e.g.: hospitalization; Central venous catheterization; infection; dehydration; surgery; trauma; immobility; use of estrogen-containing oral contraceptive pills; flare of autoimmune/rheumatologic condition).
Exclusion Criteria
(1) Prior episode of VTE
(2) Malignancy that, in the opinion of the treating oncologist, is not in remission, or for which chronic anticoagulation is being administered/anticipated to be initiated within 6 months (note: remission may exist on or off anti-neoplastic therapy)
(3) Systemic lupus erythematosus
(4) Pulmonary embolism that is not accompanied by DVT or is more proximal than segmental branches of the pulmonary artery
(5) Use of, or intent to use, thrombolytic therapy
(6) History of congenital cardiac disease for which chronic anticoagulation is being administered/ anticipated to be initiated within 6 months (e.g., for select patients or centers, in the setting of a single or hypoplastic ventricle or surgically-established cardiac shunt)
This study investigates the best treatment duration for children with blood clots in the veins. Blood clots can block veins, which are blood vessels that carry blood back to the heart. The study aims to find out how long children should be treated to balance the risk of bleeding against the risk of the clot forming again.
Participants will have follow-up scans of their clots, which are part of their regular care, to help decide the treatment length. The study will also look at how different blood thinning medicines might affect long-term outcomes. The type of blood thinner each child receives will be chosen by their doctor.
- Who can participate: Children from birth to under 21 years old with a blood clot in a vein confirmed by a scan can participate. The clot must have occurred in the past 30 days and be caused by a specific event, like surgery or infection.
- Study details: Participants will have follow-up scans of their clots to help determine how long they need to take blood thinners. The type of blood thinner will be decided by their doctor, not the study.
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