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Evaluation of the Duration of Therapy for Thrombosis in Children
Not Recruiting
Trial ID: NCT00687882
Purpose
The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to
evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3
months) anticoagulation in children with first-episode acute venous thrombosis. The first
stage of the trial has consisted of a pilot/feasibility component, which then continues as
the definitively-powered trial.
Official Title
Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children
Stanford Investigator(s)
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
John D. Louie, MD
Clinical Professor, Radiology
Eligibility
Inclusion Criteria:
1. Children (birth to <21 years of age) with radiologically-confirmed acute deep 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 (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. Chronic anticoagulant at prophylactic dosing is being or will be administered beyond 6
months post VTE diagnosis
7. Moderate/severe anticoagulant deficiency (defined by any one of the following):
1. protein C <20 IU/dL if patient is ≥3 months of age, or protein C below lower
limit of detection if patient is <3 months of age;
2. antithrombin <30 IU/dL if patient is ≥3 months of age, or antithrombin below
lower limit of detection if patient is <3 months of age;
3. protein S (free antigen or activity) <20 IU/dL.
Intervention(s):
other: Shortened duration (6 weeks) of anticoagulant therapy
other: Conventional duration (3 months) of anticoagulant therapy
other: No Intervention
other: No Intervention
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Clara Lo
650-723-5535