Candace N Mannarino1, Edward Vincent S Faustino2. 1. Yale-New Haven Hospital, New Haven, CT 06510. Electronic address: candace.mannarino@yale.edu. 2. Yale School of Medicine, New Haven, CT 06520. Electronic address: vince.faustino@yale.edu.
Abstract
PURPOSE: In preparation for a randomized controlled trial of prophylaxis against catheter-associated deep venous thrombosis in critically ill children, we aimed to determine clinical equipoise, defined as willingness to randomize children, among pediatric critical care physicians. MATERIALS AND METHODS: We conducted a cross-sectional, self-administered electronic survey of pediatric critical care physicians in the United States. The survey focused on the effect of child's age, presence of a central venous catheter, and risk (ie, presence of coagulopathy or recent surgery) and presence of bleeding on their willingness to randomize children to an anticoagulant or placebo. RESULTS: Responses from 239 (33.0%) of 725 physicians were analyzed. Respondents were willing to randomize children 1 month or older in the presence of a catheter but only those older than 13 years in the absence of a catheter. For children with coagulopathy, they would randomize those with international normalized ratio less than or equal to 2.0, partial thromboplastin time less than or equal to 50 seconds, and platelet count greater than or equal to 50000/mm(3). Respondents were willing to randomize children 2 days after most types of surgery and after 1 to 5 days of a bleeding event. CONCLUSIONS: Clinical equipoise on prophylaxis against catheter-associated thrombosis exists among pediatric critical care physicians, which ethically justifies conducting a randomized controlled trial.
PURPOSE: In preparation for a randomized controlled trial of prophylaxis against catheter-associated deep venous thrombosis in critically ill children, we aimed to determine clinical equipoise, defined as willingness to randomize children, among pediatric critical care physicians. MATERIALS AND METHODS: We conducted a cross-sectional, self-administered electronic survey of pediatric critical care physicians in the United States. The survey focused on the effect of child's age, presence of a central venous catheter, and risk (ie, presence of coagulopathy or recent surgery) and presence of bleeding on their willingness to randomize children to an anticoagulant or placebo. RESULTS: Responses from 239 (33.0%) of 725 physicians were analyzed. Respondents were willing to randomize children 1 month or older in the presence of a catheter but only those older than 13 years in the absence of a catheter. For children with coagulopathy, they would randomize those with international normalized ratio less than or equal to 2.0, partial thromboplastin time less than or equal to 50 seconds, and platelet count greater than or equal to 50000/mm(3). Respondents were willing to randomize children 2 days after most types of surgery and after 1 to 5 days of a bleeding event. CONCLUSIONS: Clinical equipoise on prophylaxis against catheter-associated thrombosis exists among pediatric critical care physicians, which ethically justifies conducting a randomized controlled 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