Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00687882
Recruitment Status : Recruiting
First Posted : June 2, 2008
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Neil Goldenberg, Johns Hopkins University

Brief 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.

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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 609 participants
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
Study Start Date : March 2008
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Efficacy outcome - Occurrence of symptomatic recurrent venous thromboembolism [ Time Frame: 1 Year ]
    Occurrence of symptomatic recurrent venous thromboembolism. Primary safety endpoint is occurrence of clinically-relevant bleeding (major + clinically-relevant non-major) bleeding.

  2. Safety outcome - Occurrence of clinically-relevant (i.e. major plus clinically-relevant non-major [CRNM] [ Time Frame: 1 year ]
    Occurrence of clinically-relevant (i.e. major plus clinically-relevant non-major [CRNM] bleeding


Secondary Outcome Measures :
  1. Efficacy outcome 1 - Occurrence of symptomatic recurrent venous thromboembolism (VTE) or development of Post Thrombotic Syndrome (PTS) (composite endpoint) [ Time Frame: 1 year ]
    Occurrence of symptomatic recurrent venous thromboembolism (VTE) or development of Post Thrombotic Syndrome (PTS) (composite endpoint)

  2. Efficacy outcome 2 - Occurrence of symptomatic recurrent venous thromboembolism (VTE) [ Time Frame: 2 years ]
    Occurrence of symptomatic recurrent venous thromboembolism (VTE)

  3. Efficacy outcome 3 - Development of Post Thrombotic Syndrome (PTS) [ Time Frame: 1 year ]
    Development of Post Thrombotic Syndrome (PTS)

  4. Efficacy outcome 4 - Development of Post Thrombotic Syndrome (PTS) [ Time Frame: 2 years ]
    Development of Post Thrombotic Syndrome (PTS)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 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.

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
Layout table for location 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 63 Study Locations
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Neil A Goldenberg, MD, PhD Johns Hopkins All Children's Hospital

Additional Information:
Publications:
Layout table for additonal information
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 Posted: June 2, 2008    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
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:
Layout table for MeSH terms
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Antibodies
Antibodies, Antiphospholipid
Anticoagulants
Physiological Effects of Drugs
Immunologic Factors