Literature DB >> 16009401

Difficulties in performing clinical trials of antithrombotic therapy in neonates and children.

M Patricia Massicotte1, Marianne Sofronas, Gabrielle deVeber.   

Abstract

The practice of evidence-based medicine is based on the results of properly designed, conducted and analyzed studies. Evidence for the safety and efficacy of therapies is established through clinical trials. However, there are a number of difficulties in the design and management of clinical trials in children. We explore the theoretical and ethical issues and difficulties of designing and conducting clinical trials in children, and illustrate the ways in which these challenges were encountered in two clinical trials assessing anticoagulant therapy in children with thrombophilia (PROTEKT (PROphylaxis of ThromboEmbolism in Kids Trial) and REVIVE (REVIparin in Venous ThromboEmbolism)). Means for overcoming these challenges are also addressed.

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Year:  2005        PMID： 16009401     DOI： 10.1016/j.thromres.2005.05.020

Source DB:  PubMed          Journal:  Thromb Res        ISSN： 0049-3848            Impact factor:   3.944


  11 in total

Review 1.  Current and future management of pediatric venous thromboembolism.

Authors:  Bryce A Kerlin
Journal:  Am J Hematol       Date:  2012-02-24       Impact factor: 10.047

2.  Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children.

Authors:  Leonardo R Brandão; Manuela Albisetti; Jacqueline Halton; Lisa Bomgaars; Elizabeth Chalmers; Lesley G Mitchell; Ildar Nurmeev; Pavel Svirin; Tomas Kuhn; Ondrej Zapletal; Igor Tartakovsky; Monika Simetzberger; Fenglei Huang; Zhichao Sun; Jörg Kreuzer; Savion Gropper; Martina Brueckmann; Matteo Luciani
Journal:  Blood       Date:  2020-02-13       Impact factor: 22.113

3.  Mortality-adjusted duration of mechanical ventilation in critically ill children with symptomatic central venous line-related deep venous thrombosis.

Authors:  Edward Vincent S Faustino; Karla A Lawson; Veronika Northrup; Renee A Higgerson
Journal:  Crit Care Med       Date:  2011-05       Impact factor: 7.598

4.  Predictive value of pediatric thrombosis diagnoses in the Danish National Patient Registry.

Authors:  Ruta Tuckuviene; Soeren Risom Kristensen; Jon Helgestad; Anette Luther Christensen; Soeren Paaske Johnsen
Journal:  Clin Epidemiol       Date:  2010-08-09       Impact factor: 4.790

Review 5.  [Prevention of perioperative venous thromboembolism in children].

Authors:  Werner Streif
Journal:  Wien Med Wochenschr       Date:  2009-10

6.  A multi-national trial of a direct oral anticoagulant in children with cardiac disease: Design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study.

Authors:  R Mark Payne; Kristin M Burns; Andrew C Glatz; Danshi Li; Xiaodong Li; Paul Monagle; Jane W Newburger; Elizabeth A Swan; Olivia Wheaton; Christoph Male
Journal:  Am Heart J       Date:  2019-08-09       Impact factor: 4.749

7.  Diagnostic accuracy of point-of-care ultrasound for catheter-related thrombosis in children.

Authors:  Simon Li; Cicero T Silva; Adele R Brudnicki; Kenneth E Baker; Joana A Tala; Matthew G Pinto; Lee A Polikoff; Li Qin; E Vincent S Faustino
Journal:  Pediatr Radiol       Date:  2015-10-06

8.  Warfarin anticoagulation after congenital heart surgery at a large children's hospital.

Authors:  Adam W Lowry; Brady S Moffett; Douglas Moodie; Jarrod D Knudson
Journal:  Pediatr Cardiol       Date:  2012-05-16       Impact factor: 1.655

Review 9.  Inherited and acquired risk factors for arterial ischemic stroke in childhood.

Authors:  Giuseppe Lippi; Massimo Franchini; Martina Montagnana; Gian Luca Salvagno; Giovanni Targher; Gian Cesare Guidi
Journal:  J Thromb Thrombolysis       Date:  2008-02-10       Impact factor: 2.300

10.  Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial.

Authors:  E Vincent S Faustino; Veronika Shabanova; Leslie J Raffini; Sarah B Kandil; Simon Li; Matthew G Pinto; Jill M Cholette; Sheila J Hanson; Marianne E Nellis; Cicero T Silva; Ranjit Chima; Anjali Sharathkumar; Kimberly A Thomas; Tara McPartland; Joana A Tala; Philip C Spinella
Journal:  Crit Care Med       Date:  2021-03-01       Impact factor: 9.296
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