Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by All Children’s Hospital Johns Hopkins Medicine
Sponsor:
Information provided by (Responsible Party):
All Children’s Hospital Johns Hopkins Medicine
ClinicalTrials.gov Identifier:
NCT00687882
First received: May 6, 2008
Last updated: June 16, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Venous Thrombosis
Other: Shortened duration (6 weeks) of anticoagulant therapy
Other: Conventional duration (3 months) of anticoagulant therapy
Other: No Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children

Resource links provided by NLM:


Further study details as provided by All Children’s Hospital Johns Hopkins Medicine:

Primary Outcome Measures:
  • Bivariate endpoint. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

    Primary efficacy endpoint is the risk of symptomatic, radiologically-confirmed recurrent venous thromboembolism.

    Primary safety endpoint is clinically-relevant bleeding (major + clinically-relevant non-major).



Secondary Outcome Measures:
  • Prevalence/severity of post-thrombotic syndrome. [ Time Frame: 1 and 2 Years ] [ Designated as safety issue: No ]
    PTS is measured using a standardized validated pediatric outcome instrument (Manco-Johnson instrument). Both PTS and clinically-significant PTS will be captured as secondary endpoints.


Estimated Enrollment: 750
Study Start Date: March 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention: A
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Other: Shortened duration (6 weeks) of anticoagulant therapy
Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
Active Comparator: B
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Other: Conventional duration (3 months) of anticoagulant therapy
Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
Other: No Intervention
Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
Other: No Intervention
Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.

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  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687882

Contacts
Contact: Neil A Goldenberg, MD, PhD 727-767-6886 ngolden4@jhmi.edu
Contact: Frances L Hamblin, RN, BSN 727-767-2460 fhambli1@jhmi.edu

  Show 35 Study Locations
Sponsors and Collaborators
All Children’s Hospital Johns Hopkins Medicine
Investigators
Principal Investigator: Neil A Goldenberg, MD, PhD All Children’s Hospital Johns Hopkins Medicine
  More Information

Additional Information:
Publications:
Responsible Party: All Children’s Hospital Johns Hopkins Medicine
ClinicalTrials.gov Identifier: NCT00687882     History of Changes
Other Study ID Numbers: 03-0585
Study First Received: May 6, 2008
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by All Children’s Hospital Johns Hopkins Medicine:
Venous Thromboembolism
Postthrombotic Syndrome
Antithrombotic Therapy
Duration of Therapy
Children

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Anticoagulants
Antibodies, Antiphospholipid
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014