Phase 3
Completed N=532
Evaluation of the Duration of Therapy for Thrombosis in Children
Source: ClinicalTrials.gov NCT00687882 ↗Enrolled (actual)
532
Serious AEs
7.4%
Results posted
Jun 2025
Primary outcomePrimary: Efficacy Outcome - Occurrence of Symptomatic Recurrent Venous Thromboembolism — 1; 2; 2; 2 Participants
◆ Published Evidence
Established
94citations · ~24 / year
Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial.
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.
Linked Publications (2)
-
Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial.
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Outcomes in children with provoked venous thrombosis and antiphospholipid antibodies: findings from the Kids-DOTT trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Outcome - Occurrence of Symptomatic Recurrent Venous Thromboembolism |
1; 2; 2; 2 | — |
| PRIMARY Safety Outcome - Occurrence of Clinically-relevant (i.e. Major Plus Clinically-relevant Non-major (CRNM) |
1; 1; 2; 2 | — |
| SECONDARY Efficacy Outcome 1 - Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) or Development of Post Thrombotic Syndrome (PTS) (Composite Endpoint) |
36; 32; 0; 0 | — |
| SECONDARY Efficacy Outcome 2 - Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) |
3; 5 | — |
| SECONDARY Efficacy Outcome 3 - Development of Post Thrombotic Syndrome (PTS) |
35; 32; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00687882) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.