RSS-Feed abonnieren
DOI: 10.1055/a-2407-1400
Handheld Point-of-Care Devices for Snakebite Coagulopathy: A Scoping Review
Abstract
Venom-induced consumption coagulopathy (VICC) is a common complication of snakebite that is associated with hypofibrinogenemia, bleeding, disability, and death. In remote tropical settings, where most snakebites occur, the 20-minute whole blood clotting test is used to diagnose VICC. Point-of-care (POC) coagulation devices could provide an accessible means of detecting VICC that is better standardized, quantifiable, and more accurate. In this scoping review, the mechanistic reasons that previously studied POC devices have failed in VICC are considered, and evidence-based recommendations are made to prioritize certain devices for clinical validation studies. Four small studies have evaluated a POC international normalized ratio (INR) device in patients with Australian Elapid, Daboia russelii, and Echis carinatus envenoming. The devices assessed in these studies either relied on a thrombin substrate endpoint, which is known to underestimate INR in patients with hypofibrinogenemia, have been recalled due to poor accuracy, or have since been discontinued. Sixteen commercially available POC devices for measuring INR, activated clotting time, activated partial thromboplastin time, fibrinogen, D-dimer, and fibrin(ogen) degradation products have been reviewed. POC INR devices that detect fibrin clot formation, as well as a novel POC device that quantifies fibrinogen were identified, which show promise for use in patients with VICC. These devices could support more accurate allocation of antivenom, reduce the time to antivenom administration, and provide improved clinical trial outcome measurement instruments. There is an urgent need for these promising POC coagulation devices to be validated in prospective clinical snakebite studies.
Publikationsverlauf
Eingereicht: 15. Mai 2024
Angenommen: 17. August 2024
Accepted Manuscript online:
30. August 2024
Artikel online veröffentlicht:
19. November 2024
© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 Kasturiratne A, Wickremasinghe AR, de Silva N. et al. The global burden of snakebite: a literature analysis and modelling based on regional estimates of envenoming and deaths. PLoS Med 2008; 5 (11) e218
- 2 The Lancet. Snake-bite envenoming: a priority neglected tropical disease. Lancet 2017; 390 (10089): 2
- 3 Isbister GK, Currie BJ, Little M, Daly FFS, Isbister JP. Coagulopathy from tiger snake envenoming and its treatment. Pathology 2002; 34 (06) 588-590 , author reply 590
- 4 Macêdo JKA, Fox JW. Biological activities and assays of the snake venom metalloproteinases (SVMPs). In: Gopalakrishnakone P, Calvete JJ. eds. Venom Genomics and Proteomics. Dordrecht: Springer Netherlands; 2016: 211-238
- 5 Gopalakrishnan M, Saurabh S, Sagar P, Bammigatti C, Dutta TK. A simple mortality risk prediction score for viper envenoming in India (VENOMS): a model development and validation study. PLoS Negl Trop Dis 2022; 16 (02) e0010183
- 6 WHO. Guidelines for the management of snakebites, 2nd edition. World Health Organization, Regional Office for South-East Asia: New Delhi. 2016 [cited August 16, 2023]. Accessed September 16, 2024 at: https://www.who.int/publications-detail-redirect/9789290225300
- 7 WHO Regional Office for Africa. Guidelines for the prevention and clinical management of snakebite in Africa: Mauritius. 2010 [cited August 16, 2023]. Accessed September 16, 2024 at: https://apps.who.int/iris/handle/10665/204458
- 8 Escalante T, Rucavado A, Fox JW, Gutiérrez JM. Key events in microvascular damage induced by snake venom hemorrhagic metalloproteinases. J Proteomics 2011; 74 (09) 1781-1794
- 9 Abubakar IS, Abubakar SB, Habib AG. et al; Nigeria-UK EchiTab Study Group. Randomised controlled double-blind non-inferiority trial of two antivenoms for saw-scaled or carpet viper (Echis ocellatus) envenoming in Nigeria. PLoS Negl Trop Dis 2010; 4 (07) e767
- 10 Naveen A, Sahu MR, Mohanty MK, Padhi KS, Patnaik A. Fatal intracranial bleedings in a viper bite: a case report. Chin J Traumatol 2023; 26 (02) 121-124
- 11 Berling I, Brown SGA, Miteff F, Levi C, Isbister GK. Intracranial haemorrhages associated with venom induced consumption coagulopathy in Australian snakebites (ASP-21). Toxicon 2015; 102: 8-13
- 12 Lee RI, White PD. A clinical study of the coagulation time of blood. Am J Med Sci 1913; 145: 495-503
- 13 Warrell DA, Davidson NMcD, Greenwood BM. et al. Poisoning by bites of the saw-scaled or carpet viper (Echis carinatus) in Nigeria. Q J Med 1977; 46 (181) 33-62
- 14 Lamb T, Abouyannis M, de Oliveira SS. et al. The 20-minute whole blood clotting test (20WBCT) for snakebite coagulopathy-a systematic review and meta-analysis of diagnostic test accuracy. PLoS Negl Trop Dis 2021; 15 (08) e0009657
- 15 Isbister GK, Maduwage K, Shahmy S. et al. Diagnostic 20-min whole blood clotting test in Russell's viper envenoming delays antivenom administration. QJM 2013; 106 (10) 925-932
- 16 Abouyannis M, Esmail H, Hamaluba M. et al; Snakebite Global Core Outcome Set Study Group. A global core outcome measurement set for snakebite clinical trials. Lancet Glob Health 2023; 11 (02) e296-e300
- 17 Tricco AC, Lillie E, Zarin W. et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med 2018; 169 (07) 467-473
- 18 Slagboom J, Kool J, Harrison RA, Casewell NR. Haemotoxic snake venoms: their functional activity, impact on snakebite victims and pharmaceutical promise. Br J Haematol 2017; 177 (06) 947-959
- 19 Kini RM, Koh CY. Metalloproteases affecting blood coagulation, fibrinolysis and platelet aggregation from snake venoms: definition and nomenclature of interaction sites. Toxins (Basel) 2016; 8 (10) 1-27
- 20 Bos MHA, Camire RM. Procoagulant adaptation of a blood coagulation prothrombinase-like enzyme complex in australian elapid venom. Toxins (Basel) 2010; 2 (06) 1554-1567
- 21 Larréché S, Chippaux J-P, Chevillard L. et al. Bleeding and thrombosis: insights into pathophysiology of Bothrops venom-related hemostasis disorders. Int J Mol Sci 2021; 22 (17) 9643
- 22 Maduwage K, Isbister GK. Current treatment for venom-induced consumption coagulopathy resulting from snakebite. PLoS Negl Trop Dis 2014; 8 (10) e3220
- 23 Takeya H, Nishida S, Miyata T. et al. Coagulation factor X activating enzyme from Russell's viper venom (RVV-X). A novel metalloproteinase with disintegrin (platelet aggregation inhibitor)-like and C-type lectin-like domains. J Biol Chem 1992; 267 (20) 14109-14117
- 24 Khan SU, Al-Saleh SS. Biochemical characterization of a factor X activator protein purified from Walterinnesia aegyptia venom. Blood Coagul Fibrinolysis 2015; 26 (07) 772-777
- 25 Rosing J, Govers-Riemslag JW, Yukelson L, Tans G. Factor V activation and inactivation by venom proteases. Haemostasis 2001; 31 (3–6): 241-246
- 26 Manjunatha Kini R, Morita T, Rosing J. Registry of Exogenous Hemostatic Factors of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Classification and nomenclature of prothrombin activators isolated from snake venoms. Thromb Haemost 2001; 86 (02) 710-711
- 27 Kornalik F, Blombäck B. Prothrombin activation induced by Ecarin - a prothrombin converting enzyme from Echis carinatus venom. Thromb Res 1975; 6 (01) 57-63
- 28 Isolation and Characterization of Carinactivase, a Novel Prothrombin Activator in Echis carinatus Venom with a Unique Catalytic Mechanism (*) - Journal of Biological Chemistry. [cited May 15, 2023]. Accessed September 16, 2024 at: https://www.jbc.org/article/S0021-9258(18)82570-4/fulltext
- 29 Rosing J, Tans G. Structural and functional properties of snake venom prothrombin activators. Toxicon 1992; 30 (12) 1515-1527
- 30 Rao VS, Kini RM. Pseutarin C, a prothrombin activator from Pseudonaja textilis venom: its structural and functional similarity to mammalian coagulation factor Xa-Va complex. Thromb Haemost 2002; 88 (04) 611-619
- 31 Speijer H, Govers-Riemslag JW, Zwaal RF, Rosing J. Prothrombin activation by an activator from the venom of Oxyuranus scutellatus (Taipan snake). J Biol Chem 1986; 261 (28) 13258-13267
- 32 Joseph JS, Chung MCM, Jeyaseelan K, Kini RM. Amino acid sequence of trocarin, a prothrombin activator from Tropidechis carinatus venom: its structural similarity to coagulation factor Xa. Blood 1999; 94 (02) 621-631
- 33 Kini RM. The intriguing world of prothrombin activators from snake venom. Toxicon 2005; 45 (08) 1133-1145
- 34 Isbister GK. Procoagulant snake toxins: laboratory studies, diagnosis, and understanding snakebite coagulopathy. Semin Thromb Hemost 2009; 35 (01) 93-103
- 35 Swenson S, Markland Jr FS. Snake venom fibrin(ogen)olytic enzymes. Toxicon 2005; 45 (08) 1021-1039
- 36 Senthilkumaran S, David SS, Jena NN, Thirumalaikolundusubramanian P. Limitations and consumer aspects of point-of-care in snake envenomation. Emerg Med Australas 2014; 26 (02) 208
- 37 O'Rourke KM, Correlje E, Martin CL, Robertson JD, Isbister GK. Point-of-care derived INR does not reliably detect significant coagulopathy following Australian snakebite. Thromb Res 2013; 132 (05) 610-613
- 38 Celenza A, Skinner K. Comparison of emergency department point-of-care international normalised ratio (INR) testing with laboratory-based testing. Emerg Med J 2011; 28 (02) 136-140
- 39 Cubitt M, Armstrong J, McCoubrie D, White J, Williams V, Isbister GK. Point-of-care testing in snakebite: an envenomed case with false negative coagulation studies. Emerg Med Australas 2013; 25 (04) 372-373
- 40 Ullah A, Masood R, Ali I. et al. Thrombin-like enzymes from snake venom: Structural characterization and mechanism of action. Int J Biol Macromol 2018; 114: 788-811
- 41 Quick AJ. On various properties of thromboplastin (aqueous tissue extracts). Am J Physiol Legacy Content 1935; 114: 282-296
- 42 Yang R, Moosavi L. Prothrombin Time. StatPearls. Treasure Island, FL: StatPearls Publishing; 2023
- 43 World Health Organization. WHO Expert Committee on Biological Standardization, sixty-seventh report. Geneva: World Health Organization; 2017 (WHO technical report series ; no. 1004)
- 44 Mion G, Larréché S, Benois A, Petitjeans F, Puidupin M. Hemostasis dynamics during coagulopathy resulting from Echis envenomation. Toxicon 2013; 76: 103-109
- 45 Isbister GK, Scorgie FE, O'Leary MA, Seldon M, Brown SG, Lincz LF. ASP Investigators. Factor deficiencies in venom-induced consumption coagulopathy resulting from Australian elapid envenomation: Australian Snakebite Project (ASP-10). J Thromb Haemost 2010; 8 (11) 2504-2513
- 46 Patel MR, Hellkamp AS, Fox KAA. ROCKET AF Executive Committee and Investigators. Point-of-care warfarin monitoring in the ROCKET AF trial. N Engl J Med 2016; 374 (08) 785-788
- 47 CLSI. One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline—Second Edition. CLSI document H47–A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008
- 48 Smith SA, Travers RJ, Morrissey JH. How it all starts: initiation of the clotting cascade. Crit Rev Biochem Mol Biol 2015; 50 (04) 326-336
- 49 Rountree KM, Yaker Z, Lopez PP. Partial Thromboplastin Time. StatPearls. Treasure Island, FL: StatPearls Publishing; 2023
- 50 Isbister GK, Williams V, Brown SGA, White J, Currie BJ. Australian Snakebite Project Investigators. Clinically applicable laboratory end-points for treating snakebite coagulopathy. Pathology 2006; 38 (06) 568-572
- 51 Hattersley PG. Activated coagulation time of whole blood. JAMA 1966; 196 (05) 436-440
- 52 Puis L, Milojevic M, Boer C. et al; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Interact Cardiovasc Thorac Surg 2020; 30 (02) 161-202
- 53 Hill JD, Dontigny L, De Leval M, Mielke Jr CH. A simple method of heparin management during prolonged extracorporeal circulation. Ann Thorac Surg 1974; 17 (02) 129-134
- 54 Shenoy RK. Clinical and laboratory spectrum of Venom-induced consumption coagulopathy (VICC) and bedside diagnostic tests in haemotoxic snakebite in a tertiary care centre in South India: ProTIV Study. masters, Christian Medical College, Vellore. 2019 ; available at: https://www.academia.edu/122221075/Clinical_and_laboratory_spectrum_of_Venom_induced_consumption_coagulopathy_VICC_and_bedside_diagnostic_tests_in_haemotoxic_snakebite_in_a_tertiary_care_centre_in_South_India_ProTIV_Study
- 55 Stang LJ, Mitchell LG. Fibrinogen. Methods Mol Biol 2013; 992: 181-192
- 56 Kaur J, Jain A. Fibrinogen. StatPearls. Treasure Island, FL: StatPearls Publishing; 2023
- 57 Silva de Oliveira S, Campos Alves E, Dos Santos Santos A. et al. Bothrops snakebites in the Amazon: recovery from hemostatic disorders after Brazilian antivenom therapy. Clin Toxicol (Phila) 2020; 58 (04) 266-274
- 58 Sanfilippo S, Buisson L, Rouabehi H. et al. The qLabs® FIB system, a novel point-of-care technology for a rapid and accurate quantification of functional fibrinogen concentration from a single drop of citrated whole blood. Thromb Res 2023; 226: 159-164
- 59 Whitaker AN, Elms MJ, Masci PP. et al. Measurement of cross linked fibrin derivatives in plasma: an immunoassay using monoclonal antibodies. J Clin Pathol 1984; 37 (08) 882-887
- 60 Francis CW, Marder VJ, Barlow GH. Plasmic degradation of crosslinked fibrin. Characterization of new macromolecular soluble complexes and a model of their structure. J Clin Invest 1980; 66 (05) 1033-1043
- 61 Konstantinides SV, Meyer G, Becattini C. et al; The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). Eur Respir J 2019; 54 (03) 1901647
- 62 Isbister GK, Noutsos T, Jenkins S, Isoardi KZ, Soderstrom J, Buckley NA. D-dimer testing for early detection of venom-induced consumption coagulopathy after snakebite in Australia (ASP-29). Med J Aust 2022; 217 (04) 203-207
- 63 Longbottom J, Shearer FM, Devine M. et al. Vulnerability to snakebite envenoming: a global mapping of hotspots. Lancet 2018; 392 (10148): 673-684
- 64 Dart RC, Hurlbut KM, Garcia R, Boren J. Validation of a severity score for the assessment of crotalid snakebite. Ann Emerg Med 1996; 27 (03) 321-326
- 65 Wedasingha S, Silva A, Siribaddana S, Seneviratne K, Isbister GK. Comparison of bedside clotting tests for detecting venom-induced consumption coagulopathy following Sri Lankan viper envenoming. Clin Toxicol (Phila) 2022; 60 (12) 1328-1335
- 66 Abouyannis M, Aggarwal D, Lalloo DG, Casewell NR, Hamaluba M, Esmail H. Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: a systematic review. PLoS Negl Trop Dis 2021; 15 (08) e0009589
- 67 Global funding for snakebite envenoming research. [cited April 6, 2020]. Accessed September 16, 2024 at: https://wellcome.ac.uk/sites/default/files/global-funding-for-snakebite-envenoming-research-2007-2018.pdf
- 68 Isbister GK, Buckley NA, Page CB. et al; ASP Investigators. A randomized controlled trial of fresh frozen plasma for treating venom-induced consumption coagulopathy in cases of Australian snakebite (ASP-18). J Thromb Haemost 2013; 11 (07) 1310-1318
- 69 Drain PK, Hyle EP, Noubary F. et al. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis 2014; 14 (03) 239-249
- 70 Ainsworth S, Menzies SK, Casewell NR, Harrison RA. An analysis of preclinical efficacy testing of antivenoms for sub-Saharan Africa: inadequate independent scrutiny and poor-quality reporting are barriers to improving snakebite treatment and management. PLoS Negl Trop Dis 2020; 14 (08) e0008579
- 71 Potet J, Smith J, McIver L. Reviewing evidence of the clinical effectiveness of commercially available antivenoms in sub-Saharan Africa identifies the need for a multi-centre, multi-antivenom clinical trial. PLoS Negl Trop Dis 2019; 13 (06) e0007551-e0007551
- 72 World Health Organization, WHO Expert Committee on Biological Standardization (2016: Geneva Switzerland). WHO Expert Committee on Biological Standardization, sixty-seventh report. Geneva: World Health Organization; 2017. . Accessed September 16, 2024 at: https://apps.who.int/iris/handle/10665/255657
- 73 Marriott AE, Casewell NR, Lilley E, Gutiérrez J-M, Ainsworth S. Improving in vivo assays in snake venom and antivenom research: a community discussion. F1000 Res 2024; 13: 192
- 74 Knudsen C, Casewell NR, Lomonte B, Gutiérrez JM, Vaiyapuri S, Laustsen AH. Novel snakebite therapeutics must be tested in appropriate rescue models to robustly assess their preclinical efficacy. Toxins (Basel) 2020; 12 (09) 528
- 75 Target product profiles for animal plasma-derived antivenoms: antivenoms for treatment of snakebite envenoming in sub-Saharan Africa. Geneva: World Health Organization; 2023. [cited August 15, 2023]. Accessed September 16, 2024 at: https://www.who.int/publications-detail-redirect/9789240074569
- 76 Camacho E, Ramírez-Vargas G, Vargas K. et al. Neutralization, by a polyspecific antivenom, of the coagulopathy induced by the venom of Bothrops asper: assessment by standard coagulation tests and rotational thromboelastometry in a murine model. Toxicon 2023; 234: 107301
- 77 Emeis JJ, Jirouskova M, Muchitsch E-M, Shet AS, Smyth SS, Johnson GJ. A guide to murine coagulation factor structure, function, assays, and genetic alterations. J Thromb Haemost 2007; 5 (04) 670-679
- 78 De Pablo-Moreno JA, Liras A, Revuelta L. Standardization of coagulation factor V reference intervals, prothrombin time, and activated partial thromboplastin time in mice for use in factor V deficiency pathological models. Front Vet Sci 2022; 9: 846216
- 79 Foerch C, Arai K, Jin G. et al. Experimental model of warfarin-associated intracerebral hemorrhage. Stroke 2008; 39 (12) 3397-3404
- 80 Coleman D, Smith G, Lawrence R, McManus D, Diaram S, Edwards J. Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective. Bioanalysis 2017; 9 (10) 787-798
- 81 Chapman K, Chivers S, Gliddon D. et al. Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies. Drug Discov Today 2014; 19 (05) 528-532
- 82 Mohapatra B, Warrell DA, Suraweera W. et al; Million Death Study Collaborators. Snakebite mortality in India: a nationally representative mortality survey. PLoS Negl Trop Dis 2011; 5 (04) e1018
- 83 Brown NI. Consequences of neglect: analysis of the sub-Saharan African snake antivenom market and the global context. PLoS Negl Trop Dis 2012; 6 (06) e1670
- 84 Whitaker R, Whitaker S. Venom, antivenom production and the medically important snakes of India. Curr Sci 2012; 103: 635-643
- 85 Fleming KA, Horton S, Wilson ML. et al. The Lancet Commission on diagnostics: transforming access to diagnostics. Lancet 2021; 398 (10315): 1997-2050