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Blood, 15 November 2008, Vol. 112, No. 10, pp. 4003-4008.
Prepublished online as a Blood First Edition Paper on August 12, 2008; DOI 10.1182/blood-2008-03-138487.
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Submitted March 3, 2008
Accepted July 12, 2008
Severe hemorrhage in children with newly diagnosed immune thrombocytopenic purpura
Cindy E. Neunert*, George R. Buchanan, Paul Imbach, Paula H.B Bolton-Maggs, Carolyn M Bennett, Ellis J. Neufeld, Sara K Vesely, Leah Adix, Victor S. Blanchette, and Thomas Kuhne
Department of Pediatrics, Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, TX, United States
Department of Pediatrics, University Children's Hospital, Basel, Switzerland
Department of Pediatrics, Manchester Royal Infirmary, Manchester, United Kingdom
Department of Pediatrics, Children's Hospital Boston, Boston, MA, United States
Department of Epidemiology of Biostatistics, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States
Center for Cancer and Blood Disorders, Children's Medical Center Dallas, Dallas, TX, United States
Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada
* Corresponding author; email: cindy.neunert{at}utsouthwestern.edu.
Controversy exists regarding management of children newly diagnosed with immune thrombocytopenic purpura (ITP). Drug treatment is usually administered to prevent severe hemorrhage, although the definition and frequency of severe bleeding are poorly characterized. Accordingly, the Intercontinental Childhood ITP Study Group (ICIS) conducted a prospective registry defining severe hemorrhage at diagnosis and during the following 28 days in children with ITP. Of 1,106 ITP patients enrolled, 863 were eligible and evaluable for bleeding severity assessment at diagnosis and during the subsequent four weeks. Twenty-five children (2.9%) had severe bleeding at diagnosis. Among 505 patients with a platelet count  20,000 per mm3 and no or mild bleeding at diagnosis, three (0.6%), had new severe hemorrhagic events during the ensuing 28 days. Subsequent development of severe hemorrhage was unrelated to initial management (p = 0.82). These results show that severe bleeding is uncommon at diagnosis in children with ITP and rare during the next four weeks irrespective of treatment given. We conclude that it would be difficult to design an adequately powered therapeutic trial aimed at demonstrating prevention of severe bleeding during the first four weeks following diagnosis. This finding suggests that future studies of ITP management should emphasize other outcomes.
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