Education and Training
Evaluation of the Duration of Therapy for Thrombosis in Children
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- other: Shortened duration (6 weeks) of anticoagulant therapy
- other: Conventional duration (3 months) of anticoagulant therapy
- other: No Intervention
- other: No Intervention
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.
Ages Eligible for Study
N/A - 20 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Clara Lo
650-723-5535
Not Recruiting