Trial Search Results

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 accepting patients for this trial.

Lead Sponsor:

Johns Hopkins All Children's Hospital

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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

Phase:

Phase 3

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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elaine Macasiray
Recruiting