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

This study is currently recruiting participants.
Verified March 2017 by Neil Goldenberg, Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00687882
First Posted: June 2, 2008
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Neil Goldenberg, Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Neil Goldenberg, Johns Hopkins University:

Primary Outcome Measures:
  • Bivariate endpoint. [ Time Frame: 1 Year ]

    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 ]
    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: June 30, 2022
Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00687882


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

  Show 54 Study Locations
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Neil A Goldenberg, MD, PhD Johns Hopkins All Children's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Neil Goldenberg, Director of Research and Chief Research Officer, Johns Hopkins All Children's Hospital, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00687882     History of Changes
Other Study ID Numbers: IRB00063928
1U01HL130048-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2008
First Posted: June 2, 2008
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neil Goldenberg, Johns Hopkins University:
Venous Thromboembolism
Postthrombotic Syndrome
Antithrombotic Therapy
Duration of Therapy
Children

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Antibodies
Antibodies, Antiphospholipid
Anticoagulants
Immunologic Factors
Physiological Effects of Drugs