Evaluation of the Duration of Therapy for Thrombosis in Children

Trial ID or NCT#

NCT00687882

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Younger than 20 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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.
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Investigator(s)

John D. Louie, MD
John D. Louie, MD
Interventional radiologist
Clinical Professor, Radiology
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Clara Lo

Contact us to find out if this trial is right for you.

Contact

Clara Lo
650-723-5535

View on ClinicalTrials.gov