Evaluation of the Duration of Therapy for Thrombosis in Children
(Kids-DOTT Trial)
Recruiting in Palo Alto (17 mi)
+62 other locations
Overseen byNeil A Goldenberg, MD, PhD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Johns Hopkins All Children's Hospital
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
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).
Treatment Details
Interventions
- Conventional duration (3 months) of anticoagulant therapy (Anticoagulant)
- No Intervention (Other)
- Shortened duration (6 weeks) of anticoagulant therapy (Anticoagulant)
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Parallel Cohort: Persistent Occlusive ThrombosisExperimental Treatment1 Intervention
Patients with completely occlusive thrombosis at 6 weeks.
Group II: Parallel Cohort: Persistent Antiphospholipid AntibodyExperimental Treatment1 Intervention
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
Group III: Intervention: AExperimental Treatment1 Intervention
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Group IV: BActive Control1 Intervention
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cornell UniversityIthaca, NY
Akron Children's HospitalAkron, OH
Johns Hopkins MedicineBaltimore, MD
Texas Children's Hospital (Baylor)Houston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Johns Hopkins All Children's HospitalLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator