title: A randomized controlled trial of fresh frozen plasma for coagulopathy in Russell's viper (Daboia russelii) envenoming.
abstract: Essentials Russell's viper envenoming is a major health issue in South Asia and causes coagulopathy. We studied the effect of fresh frozen plasma and two antivenom doses on correcting coagulopathy. Fresh frozen plasma did not hasten recovery of coagulopathy. Low-dose antivenom did not worsen coagulopathy.
  
  
  
  Background Russell's viper (Daboia russelii) envenoming is a major health issue in South Asia and causes venom-induced consumption coagulopathy (VICC). Objectives To investigate the effects of fresh frozen plasma (FFP) and two antivenom doses in correcting VICC. Methods We undertook an open-label randomized controlled trial in patients with VICC at two Sri Lankan hospitals. Patients with suspected Russell's viper bites and coagulopathy were randomly allocated (1 : 1) to high-dose antivenom (20 vials) or low-dose antivenom (10 vials) plus 4 U of FFP. The primary outcome was the proportion of patients with an International Normalized Ratio (INR) of < 2 at 6 h after antivenom administration. Secondary outcomes included anaphylaxis, major hemorrhage, death, and clotting factor recovery. Results From 214 eligible patients, 141 were randomized: 71 to high-dose antivenom, and 70 to low-dose antivenom/FFP; five had no post-antivenom blood tests. The groups were similar except for a delay of 1 h in antivenom administration for FFP patients. Six hours after antivenom administration, 23 of 69 (33%) patients allocated to high-dose antivenom had an INR of < 2, as compared with 28 of 67 (42%) allocated to low-dose antivenom/FFP (absolute difference 8%; 95% confidence interval - 8% to 25%). Fifteen patients allocated to FFP did not receive it. Severe anaphylaxis occurred equally frequently in each group. One patient given FFP developed transfusion-related acute lung injury. Three deaths occurred in low-dose antivenom/FFP patients, including one intracranial hemorrhage. There was no difference in recovery rates of INR or fibrinogen, but there was more rapid initial recovery of factor V and FX in FFP patients. Conclusion FFP after antivenom administration in patients with Russell's viper bites did not hasten recovery of coagulopathy. Low-dose antivenom/FFP did not worsen VICC, suggesting that low-dose antivenom is sufficient.
authors.affiliation: Clinical Toxicology Research Group, University of Newcastle, Newcastle, New South Wales, Australia.|South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: G K
authors.initials: GK
authors.lastname: Isbister
authors.affiliation: South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.|Department of Medicine, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
authors.forename: S
authors.initials: S
authors.lastname: Jayamanne
authors.affiliation: South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: F
authors.initials: F
authors.lastname: Mohamed
authors.affiliation: South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.|Department of Pharmacology, SOMS, Sydney Medical School, University of Sydney, New South Wales, Australia.
authors.forename: A H
authors.initials: AH
authors.lastname: Dawson
authors.affiliation: Clinical Toxicology Research Group, University of Newcastle, Newcastle, New South Wales, Australia.|South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.|Department of Biochemistry, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: K
authors.initials: K
authors.lastname: Maduwage
authors.affiliation: South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.|Department of Medicine, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.
authors.forename: I
authors.initials: I
authors.lastname: Gawarammana
authors.affiliation: Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
authors.forename: D G
authors.initials: DG
authors.lastname: Lalloo
authors.affiliation: South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.|Department of Medicine, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
authors.forename: H J
authors.initials: HJ
authors.lastname: de Silva
authors.affiliation: Hunter Haematology Research Group, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
authors.forename: F E
authors.initials: FE
authors.lastname: Scorgie
authors.affiliation: Hunter Haematology Research Group, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
authors.forename: L F
authors.initials: LF
authors.lastname: Lincz
authors.affiliation: South Asian Clinical Toxicology Research Collaboration, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka.|Department of Pharmacology, SOMS, Sydney Medical School, University of Sydney, New South Wales, Australia.
authors.forename: N A
authors.initials: NA
authors.lastname: Buckley
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000997:Antivenins / Q000627:therapeutic use*; D001777:Blood Coagulation; D001779:Blood Coagulation Factors / Q000008:administration & dosage; D004211:Disseminated Intravascular Coagulation / Q000209:etiology / Q000628:therapy*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011446:Prospective Studies; D017840:Daboia; D012909:Snake Bites / Q000628:therapy*; D013188:Sri Lanka; D013997:Time Factors; D016896:Treatment Outcome; D014757:Viper Venoms
chemical_list: D000997:Antivenins; D001779:Blood Coagulation Factors; D014757:Viper Venoms
keywords: antivenoms; consumption coagulopathy; plasma; snake venoms; snakebites