BACKGROUND: Randomized controlled trials (RCTs) on pediatric @entity1211 ( @entity1211 ) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS: The Kids-DOTT trial is a multicenter RCT investigating non-inferiority of a 6-week (shortened) versus 3-month (conventional) duration of anticoagulation in @entity1 aged <  21  years with provoked @entity49 . Primary efficacy and safety endpoints are symptomatic recurrent @entity1211 at 1  year and anticoagulant-related, clinically relevant @entity548 . In the P/F phase, 100 @entity1 were enrolled in an open, blinded-endpoint, parallel-cohort RCT design. RESULTS: No eligibility violations or randomization errors occurred. Of the enrolled @entity1 , 69% were randomized, 3% missed the randomization window, and 28% were followed in prespecified observational cohorts for completely occlusive @entity715 or persistent antiphospholipid antibodies. Retention at 1  year was 82%. Interobserver agreement between local and blinded central determination of @entity432 by imaging at 6  weeks after diagnosis was strong (k-statistic  =  0.75; 95% confidence interval [CI]  0.48-1.0). The primary efficacy and safety event rates were 3.3% (95%  CI  0.3-11.5%) and 1.4% (95%  CI  0.03-7.4%). CONCLUSIONS: The P/F phase of the Kids-DOTT trial has demonstrated the validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention and endpoint rates to inform the fully powered RCT.

Multicenter randomized controlled trial on Duration of Therapy for @entity715 in XXXX and Young Adults (the  Kids-DOTT trial): pilot/feasibility phase findings.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity49 :: ('MESH:D019851', 'Disease') :: ['venous thrombosis'] @entity432 :: ('MESH:D001157', 'Disease') :: ['venous occlusion'] @entity715 :: ('MESH:D013927', 'Disease') :: ['thrombosis'] @entity1211 :: ('MESH:D054556', 'Disease') :: ['VTE', 'venous thromboembolism']
@entity1 :: (9606,Species) :: ['Children']
