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A Prospective Observational Study to Determine the Predictive Accuracy of Snakebite Severity Score (SSS) in Identifying Syndrome-Specific Core Outcome Parameters Amongst Envenomated Patients Presenting to the Emergency Department.

Sponsor: Jubilee Mission Medical College and Research Institute

Summary

India reports \~58,000 snakebite deaths/year, over 50% of global mortality. Clinical outcomes of antivenom may vary due to regional venom differences, delayed access to care, ineffective use of existing polyvalent antivenom. There is a need for an India-specific severity assessment tool because it improves risk stratification \& clinical decisions ,guides antivenom use, supports rural healthcare infrastructure, reduces morbidity, mortality, and financial burden. Existing scoring systems lack validation for Indian envenomation patterns. Variability in venom (both inter- and intra-species) leads to inconsistent clinical outcomes.Misapplication of non-Indian tools may cause: Inaccurate severity grading, inappropriate antivenom use, poor patient outcomes. PRIMARY OBJECTIVE: ● To determine the predictive accuracy of Snakebite Severity Score (SSS) done at the time of presentation in identifying syndrome specific core outcomes for snakebites. SECONDARY OBJECTIVES: * To evaluate the predictive accuracy of SSS in identifying patients at risk of mortality at 6 weeks * To determine the predictive accuracy of modified Snakebite Severity Score (mSSS) done at the time of presentation in identifying syndrome specific core outcomes for snakebites METHODOLOGY Study Duration: 18 months (Proposed) * Setting: Emergency Dept, Jubilee Mission Medical College * Sampling method :consecutive sampling * Sample Size Calculation: n = Z₍₁-α/₂)2 x SN (100-SN ) / l2 x P = 220 * Confidence Level: 95% (Z₍₁-α/₂₎ = 1.96) * Expected Sensitivity: 97% * Relative Allowable Error: 5% (l = 0.05) * Proportion: Based on core outcome occurrence = 0.22 * Drop-out Rate Assumed: 20% * minimum sample size = 264 Reference: Based on data from Dart et al."Validation of a Severity Score for the Assessment of Crotalid Snakebite,1999" INCLUSION AND EXCLUSION CRITERIA Inclusion Criteria: * All patients 'clinically suspected snakebite' * Presenting within 24 hours of the event * Age ≥18 years * Providing written informed consent Exclusion Criteria * Stings or bites other than snake * All patients who received antivenom or blood products at another institute * All patients with known hematological malignancies, coagulation disorders, chronic liver or renal failure * All patients known to be on warfarin, heparin or any newer oral or injectable anticoagulants * Individuals withdrawing a consent later on. STUDY FLOW AND DATA MANAGEMENT Study Flow: Enrollment \& Initial ED Assessment: History, examination, bite documentation, SSS scoring Baseline labs as per institutional protocol Monitoring \& Follow-Up Timepoints: T0: At presentation T+3h, +6h, +12h: Direct proforma, records review T+48h: Medical records Day 30 and Day 42 : Medical records \& telephonic follow-up Outcomes Monitored: Neurotoxicity, haemotoxicity , coagulopathy, local damage, AKI, hypotension No interference with clinical care or treatment decisions. DATA ANALYSIS PLAN: Software: SPSS v29 Continuous variables are measured by using Mean+/-SD or median IQR Categorical variables are reported as frequencies and percentages. ROC curve analysis for SSS and mSSS. Logistic regression for mortality. Subgroup and domain-wise analysis. ETHICAL CONSIDERATIONS: Ethics approval to be obtained. Informed consent will be ensured. Data anonymized and securely stored. No interference with patient treatment.

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