Evaluation of the Duration of Therapy for Thrombosis in Children

Completed · Phase 3

Conditions studied: Venous Thrombosis

In brief

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.

Key facts

Study ID

NCT00687882

Run by

Johns Hopkins All Children's Hospital

People needed

532

Starts

2008-03-01

Expected to finish

2022-02-15

Last updated by the study team

2025-06-18

Who can join

Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children (birth to <21 years of age) with radiologically-confirmed acute deep venous thrombosis in the past 30 days
• 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).

You may not qualify if…

• Prior episode of VTE
• Malignancy that, in the opinion of the treating oncologist, is not in remission (note: remission may exist on or off anti-neoplastic therapy)
• Systemic lupus erythematosus
• Pulmonary embolism that is not accompanied by DVT or is more proximal than segmental branches of the pulmonary artery
• Use of, or intent to use, thrombolytic therapy
• Chronic anticoagulant at prophylactic dosing is being or will be administered beyond 6 months post VTE diagnosis
• Moderate/severe anticoagulant deficiency (defined by any one of the following):
• 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;
• 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;
• protein S (free antigen or activity) <20 IU/dL.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Orange County — Orange, California, United States
• Stanford Medicine — Palo Alto, California, United States
• UC Davis Children's Center — Sacramento, California, United States
• Rady Children's Hospital UCSD — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• George Washington University, Children's National Medical Center — Washington D.C., District of Columbia, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Emory University / Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
• University of Iowa Stead Family Children's Hospital — Iowa City, Iowa, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins Medicine — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Hospital of Michigan, Wayne State University — Detroit, Michigan, United States
• Michigan State University — East Lansing, Michigan, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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