PROSPECTIVE MULTI-CENTER EVALUATION OF THE DURATION OF THERAPY FOR THROMBOSIS IN CHILDREN (the "Kids-DOTT" Trial)

K
Kerry Hege, MD

Primary Investigator

Overview

This study plans to learn more about the best type of treatment for children with blood clots in the veins.

Description

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

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Thrombosis
  • Age: - 20 Years
  • 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)

Updated on 09 Mar 2024. Study ID: 1811174490

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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