Evaluation of the Duration of Therapy for Thrombosis in Children (Kids-DOTT)
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ClinicalTrials.gov Identifier: NCT00687882 |
Recruitment Status
:
Recruiting
First Posted
: June 2, 2008
Last Update Posted
: March 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Estimated Enrollment : | 815 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention: A
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
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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.
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Active Comparator: B
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
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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.
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Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
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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.
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Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
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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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- 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).
- 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.

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Ages Eligible for Study: | up to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children (birth to <21 years of age) with radiologically-confirmed acute venous thrombosis in the past 30 days
- 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:
- Prior episode of VTE
- Malignancy that, in the opinion of the treating oncologist, is not in remission, or for which chronic anticoagulation is being administered/anticipated to be initiated within 6 months (note: remission may exist on or off anti-neoplastic therapy)
- Systemic lupus erythematosus
- Pulmonary embolism that is not accompanied by DVT or is more proximal than segmental branches of the pulmonary artery
- Use of, or intent to use, thrombolytic therapy
- History of congenital cardiac disease for which chronic anticoagulation is being administered/ anticipated to be initiated within 6 months (e.g., for select patients or centers, in the setting of a single or hypoplastic ventricle or surgically-established cardiac shunt)
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Moderate/severe anticoagulant deficiency as defined by any one of the following:
- 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;
- 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;
- protein S (free antigen or activity) <20 IU/dL.

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
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 |

Principal Investigator: | Neil A Goldenberg, MD, PhD | Johns Hopkins All Children's Hospital |
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 Posted: | June 2, 2008 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | March 2018 |
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 |