CompletedPhase 3

Evaluation of the Duration of Therapy for Thrombosis in Children

United States532 participantsStarted 2008-03

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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;

What they're measuring

Efficacy Outcome - Occurrence of Symptomatic Recurrent Venous Thromboembolism

Timeframe: 1 Year

Safety Outcome - Occurrence of Clinically-relevant (i.e. Major Plus Clinically-relevant Non-major (CRNM)

Timeframe: 1 year

Trial details

NCT IDNCT00687882

SponsorJohns Hopkins All Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-05

Results submitted2025-03-12

View on ClinicalTrials.gov More Venous Thrombosis trials