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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1324-5906 | Other Identifier | World Health Organisation |
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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:
METHODOLOGY Study Duration: 18 months (Proposed)
n = Z₍₁-α/₂)2 x SN (100-SN ) / l2 x P = 220
INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria:
Exclusion Criteria
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ● All patients 'clinically suspected snakebite' ● Presenting within 24 hours of the event ● Age ≥ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol | Other | Following enrollment, an initial clinical assessment will be conducted in the Emergency Department (ED). This includes history taking, physical examination, documentation of bite characteristics, and calculation of the Snakebite Severity Score (SSS) at presentation. Baseline laboratory investigations will be performed as per institutional protocol. All participants will undergo serial clinical and laboratory monitoring as per institutional protocol. The development of syndrome-specific core outcomes, including neurotoxicity, haemotoxicity, coagulopathy, local tissue damage, acute kidney injury, and hypotension (Annexure) would be followed-up and evaluations will be conducted at the following time points: At presentation, Within 3 hours of ED admission, Within 6 hours of ED admission, Within 12 hours of ED admission |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) and area under the curve (AUC) of the Snakebite Severity Score (SSS) recorded at the time of emergency department presentation | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the predictive accuracy of the SSS score at presentation in identifying patients who develop all-cause mortality within 6 weeks, using diagnostic performance metrics (AUC, sensitivity, specificity, PPV, NPV). | 2 years | |
| To compare the predictive performance (AUC, sensitivity, specificity) of the Modified Snakebite Severity Score (mSSS) at presentation in detecting syndrome-specific core outcomes, over a 30-day follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients presenting to the Emergency Medicine Department of Jubilee Mission Medical College with clinically suspected snakebite envenomation will be screened for eligibility. Patients who meet the inclusion criteria and provide written informed consent will be enrolled in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feba Susan Kurian, MBBS | Contact | 919061984552 | febasusankurian1999@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jubilee Medical Mission and Research Institute | Thrissur | Kerala | 680005 | India |
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|
| 2 years |
| ID | Term |
|---|---|
| D012909 | Snake Bites |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
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