Evaluation of the Duration of Therapy for Thrombosis in Children

Status: Recruiting
Phase: Phase 3
DFCI Protocol ID:

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.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Cameron Trenor, MD, Children's Hospital Boston

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  1. Children (birth to <21 years of age) with radiologically-confirmed acute 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. presence or history of cancer;

  3. systemic lupus erythematosus

  4. known pulmonary embolism (PE), except when limited to peripheral cavitary lesions
     representing septic emboli; (N.B. imaging for PE should only have been based upon
     clinical signs/symptoms, and is not a study procedure or requirement)

  5. Use of, or intent to use, thrombolytic therapy

  6. Patients with congenital cardiac disease involving a single or hypoplastic ventricle
     or otherwise requiring an intracardiac shunt

  7. Moderate/severe anticoagulant deficiency as 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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