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

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dc.contributor.authorBush, Sean P.
dc.contributor.authorRuha, Anne-Michelle
dc.contributor.authorSeifert, Steven A.
dc.contributor.authorMorgan, David L.
dc.contributor.authorLewis, Brandon J.
dc.contributor.authorArnold, Thomas C.
dc.contributor.authorClark, Richard F.
dc.contributor.authorMeggs, William J.
dc.contributor.authorToschlog, Eric A.
dc.contributor.authorBorron, Stephen W.
dc.contributor.authorFigge, Gary R.
dc.contributor.authorSollee, Dawn R.
dc.contributor.authorShirazi, Farshad M.
dc.contributor.authorWolk, Robert
dc.contributor.authorde Chazal, Ives
dc.contributor.authorQuan, Dan
dc.contributor.authorGarcía-Ubbelohde, Walter
dc.contributor.authorAlagón, Alejandro
dc.contributor.authorGerkin, Richard D.
dc.contributor.authorBoyer, Leslie V.
dc.date.accessioned2016-05-26T14:37:23Z
dc.date.available2016-05-26T14:37:23Z
dc.date.issued2015-01
dc.description.abstractBACKGROUND: 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.en_US
dc.identifier.citationClinical Toxicology (Philadelphia, Pa.); 53:1 p. 37-45en_US
dc.identifier.doi10.3109/15563650.2014.974263
dc.identifier.issn1556-3650
dc.identifier.pmidpmc4364250en_US
dc.identifier.urihttp://hdl.handle.net/10342/5371
dc.relation.urihttp://www.ncbi.nlm.nih.gov/pubmed/25361165en_US
dc.subjectAntiveninsen_US
dc.subjectSnakesen_US
dc.subjectToxinologyen_US
dc.titleComparison of F(ab') versus Fab antivenom for pit viper envenomation: A prospective, blinded, multicenter, randomized clinical trialen_US
dc.typeArticleen_US
ecu.journal.issue1en_US
ecu.journal.nameClinical Toxicology (Philadelphia, Pa.)en_US
ecu.journal.pages37-45en_US
ecu.journal.volume53en_US

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