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.