title: Severe hemorrhage in children with newly diagnosed immune thrombocytopenic purpura.
abstract: 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 1106 ITP patients enrolled, 863 were eligible and evaluable for bleeding severity assessment at diagnosis and during the subsequent 4 weeks. Twenty-five children (2.9%) had severe bleeding at diagnosis. Among 505 patients with a platelet count less than or equal to 20 000/mm(3) and no or mild bleeding at diagnosis, 3 (0.6%), had new severe hemorrhagic events during the ensuing 28 days. Subsequent development of severe hemorrhage was unrelated to initial management (P = .82). These results show that severe bleeding is uncommon at diagnosis in children with ITP and rare during the next 4 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 4 weeks after diagnosis. This finding suggests that future studies of ITP management should emphasize other outcomes.
authors.affiliation: University of Texas Southwestern Medical Center at Dallas, USA. cindy.neunert@utsouthwestern.edu
authors.forename: Cindy E
authors.initials: CE
authors.lastname: Neunert
authors.forename: George R
authors.initials: GR
authors.lastname: Buchanan
authors.forename: Paul
authors.initials: P
authors.lastname: Imbach
authors.forename: Paula H B
authors.initials: PH
authors.lastname: Bolton-Maggs
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Bennett
authors.forename: Ellis J
authors.initials: EJ
authors.lastname: Neufeld
authors.forename: Sara K
authors.initials: SK
authors.lastname: Vesely
authors.forename: Leah
authors.initials: L
authors.lastname: Adix
authors.forename: Victor S
authors.initials: VS
authors.lastname: Blanchette
authors.forename: Thomas
authors.initials: T
authors.lastname: Kühne
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy; D006801:Humans; D007223:Infant; D008297:Male; D010976:Platelet Count; D011446:Prospective Studies; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000097:blood / Q000150:complications / Q000175:diagnosis* / Q000628:therapy; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors