Status:
COMPLETED
Evaluation of the Duration of Therapy for Thrombosis in Children
Lead Sponsor:
Johns Hopkins All Children's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Venous Thrombosis
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE3
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) anticoagula...
Detailed Description
Children (birth to 21 years of age, inclusive) with first-episode venous thrombosis in association with a reversible clinical trigger (key exclusions: history of cancer; severe thrombophilia state dis...
Eligibility Criteria
Inclusion
- Children (birth to \<21 years of age) with radiologically-confirmed acute deep 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
- Prior episode of VTE
- Malignancy that, in the opinion of the treating oncologist, is not in remission (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
- Chronic anticoagulant at prophylactic dosing is being or will be administered beyond 6 months post VTE diagnosis
- Moderate/severe anticoagulant deficiency (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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00687882
Start Date
March 1 2008
End Date
February 15 2022
Last Update
June 18 2025
Active Locations (63)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
4
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027