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    Comparison of F(ab') versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial

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    Author
    Bush, Sean P.; Ruha, Anne-Michelle; Seifert, Steven A.; Morgan, David L.; Lewis, Brandon J.; Arnold, Thomas C.; Clark, Richard F.; Meggs, William J.; Toschlog, Eric A.; Borron, Stephen W.; Figge, Gary R.; Sollee, Dawn R.; Shirazi, Farshad M.; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D.; Boyer, Leslie V.
    Abstract
    BACKGROUND: Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. METHODS: We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count < 150 K/mm(3), fibrinogen level < 150 mg/dL) between end of maintenance dosing and day 8. RESULTS: 121 patients were randomized at 18 clinical sites and received at least one dose of study drug. 114 completed the study. Of these, 11/37 (29.7%) in the Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. CONCLUSIONS: In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation.
    URI
    http://hdl.handle.net/10342/5371
    Subject
     Antivenins; Snakes; Toxinology 
    Date
    2015-01
    Citation:
    APA:
    Bush, Sean P., & Ruha, Anne-Michelle, & Seifert, Steven A., & Morgan, David L., & Lewis, Brandon J., & Arnold, Thomas C., & Clark, Richard F., & Meggs, William J., & Toschlog, Eric A., & Borron, Stephen W., & Figge, Gary R., & Sollee, Dawn R., & Shirazi, Farshad M., & Wolk, Robert, & de Chazal, Ives, & Quan, Dan, & García-Ubbelohde, Walter, & Alagón, Alejandro, & Gerkin, Richard D., & Boyer, Leslie V.. (January 2015). Comparison of F(ab') versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial. Clinical Toxicology (Philadelphia, Pa.), (53:1), p.37-45. Retrieved from http://hdl.handle.net/10342/5371

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    MLA:
    Bush, Sean P., and Ruha, Anne-Michelle, and Seifert, Steven A., and Morgan, David L., and Lewis, Brandon J., and Arnold, Thomas C., and Clark, Richard F., and Meggs, William J., and Toschlog, Eric A., and Borron, Stephen W., and Figge, Gary R., and Sollee, Dawn R., and Shirazi, Farshad M., and Wolk, Robert, and de Chazal, Ives, and Quan, Dan, and García-Ubbelohde, Walter, and Alagón, Alejandro, and Gerkin, Richard D., and Boyer, Leslie V.. "Comparison of F(ab') versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial". Clinical Toxicology (Philadelphia, Pa.). 53:1. (37-45.), January 2015. August 17, 2022. http://hdl.handle.net/10342/5371.
    Chicago:
    Bush, Sean P. and Ruha, Anne-Michelle and Seifert, Steven A. and Morgan, David L. and Lewis, Brandon J. and Arnold, Thomas C. and Clark, Richard F. and Meggs, William J. and Toschlog, Eric A. and Borron, Stephen W. and Figge, Gary R. and Sollee, Dawn R. and Shirazi, Farshad M. and Wolk, Robert and de Chazal, Ives and Quan, Dan and García-Ubbelohde, Walter and Alagón, Alejandro and Gerkin, Richard D. and Boyer, Leslie V., "Comparison of F(ab') versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial," Clinical Toxicology (Philadelphia, Pa.) 53, no. 1 (January 2015), http://hdl.handle.net/10342/5371 (accessed August 17, 2022).
    AMA:
    Bush, Sean P., Ruha, Anne-Michelle, Seifert, Steven A., Morgan, David L., Lewis, Brandon J., Arnold, Thomas C., Clark, Richard F., Meggs, William J., Toschlog, Eric A., Borron, Stephen W., Figge, Gary R., Sollee, Dawn R., Shirazi, Farshad M., Wolk, Robert, de Chazal, Ives, Quan, Dan, García-Ubbelohde, Walter, Alagón, Alejandro, Gerkin, Richard D., Boyer, Leslie V.. Comparison of F(ab') versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trial. Clinical Toxicology (Philadelphia, Pa.). January 2015; 53(1) 37-45. http://hdl.handle.net/10342/5371. Accessed August 17, 2022.
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