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Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids‐DOTT trial): pilot/feasibility phase findings by N.A. Goldenberg; T. Abshire; P.J. Blatchford; L.Z. Fenton; J.L. Halperin; W.R. Hiatt; C.M. Kessler; J.M. Kittelson; M.J. Manco‐Johnson; A.C. Spyropoulos; P.G. Steg; N.V. Stence; A.G.G. Turpie; S. Schulman; R. Punzalan; M. Wang; J. Jaffray; G. Young; M. Rajpurkar; S. Carpenter; Y. Diab; N. Verdun; C. Tarango; S. Acharya; M. Torres; N. Kucine; B. Mitchell; N. Shah; C. Thornburg; C. Takemoto; R. Kulkarni; S. O'Brien; K. Haley; M. Recht; C. Knoll; C. Thornburg; A. Geddis; S. Ahuja; M. Simpson; L. Srivaths; J. Journeycake; A. Zia is a Medicine article available to read on EtoBox.

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## Background: Randomized controlled trials (rcts) on pediatric venous thromboembolism (vte) 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 patients aged < 21 years with provoked venous thrombosis. primary efficacy and safety endpoints are symptomatic recurrent vte at 1 year and anticoagulant-related, clinically relevant bleeding. in the p/f phase, 100 participants were enrolled in an open, blinded-endpoint, parallel-cohort rct design. ## Results: No eligibility violations or randomization errors occurred. of the enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in prespecified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. retention at 1 year was 82%. interobserver agreement between local and blinded central determination of venous occlusion by imaging at 6 weeks after diagnosis was strong (k-statistic = 0.

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Author

N.A. Goldenberg; T. Abshire; P.J. Blatchford; L.Z. Fenton; J.L. Halperin; W.R. Hiatt; C.M. Kessler; J.M. Kittelson; M.J. Manco‐Johnson; A.C. Spyropoulos; P.G. Steg; N.V. Stence; A.G.G. Turpie; S. Schulman; R. Punzalan; M. Wang; J. Jaffray; G. Young; M. Rajpurkar; S. Carpenter; Y. Diab; N. Verdun; C. Tarango; S. Acharya; M. Torres; N. Kucine; B. Mitchell; N. Shah; C. Thornburg; C. Takemoto; R. Kulkarni; S. O'Brien; K. Haley; M. Recht; C. Knoll; C. Thornburg; A. Geddis; S. Ahuja; M. Simpson; L. Srivaths; J. Journeycake; A. Zia

Published

2015

Language

EN

Field

Medicine (Health Sciences)