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. (SCOPE-Snake)

Jubilee Mission Medical College and Research Institute

Status: Not yet enrolling

Conditions: Snake Bite

Treatments: Other: History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol

Study type: Observational

Funder types: Other

Identifiers

NCT07079137

67/25/IEC/JMMC&RI

U1111-1324-5906 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 1 patient group

● All patients 'clinically suspected snakebite' ● Presenting within 24 hours of the event ● Age ≥

Treatment:

Other: History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol