An observational study in Snake Bite, sponsored by Jubilee Mission Medical College and Research Institute. Recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Jubilee Mission Medical College and Research Institute · Observational
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's planned enrollment of 220 is above the median of 99 across 19 observational studies indexed under Snake Bites.
Browse Snake Bites studies →Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol
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
Performance of the Snakebite Severity Score (SSS) at Emergency Department Presentation in Predicting Syndrome-Specific Core Outcomes
The performance of the Snakebite Severity Score (SSS), recorded at the time of emergency department presentation, will be assessed for predicting the occurrence of predefined syndrome-specific core outcomes during the follow-up period. The syndrome-specific core outcomes include neurotoxicity, haemotoxicity/coagulopathy, local tissue damage, acute kidney injury, and hypotension, as defined in the study protocol. Performance will be evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Time frame: SSS assessed at emergency department presentation; syndrome-specific core outcomes assessed from presentation through 30 days
Performance of the Snakebite Severity Score (SSS) at Emergency Department Presentation in Predicting All-Cause Mortality Within 6 Weeks
The performance of the Snakebite Severity Score (SSS), recorded at the time of emergency department presentation, will be assessed for predicting all-cause mortality during the 6-week follow-up period. Performance will be evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Time frame: SSS assessed at emergency department presentation; all-cause mortality assessed through 6 weeks
Performance of the Modified Snakebite Severity Score (mSSS) at Emergency Department Presentation in Predicting Syndrome-Specific Core Outcomes Within 30 Days
The performance of the Modified Snakebite Severity Score (mSSS), calculated at the time of emergency department presentation, will be assessed for predicting the occurrence of predefined syndrome-specific core outcomes during the 30-day follow-up period. The syndrome-specific core outcomes include neurotoxicity, haemotoxicity/coagulopathy, local tissue damage, acute kidney injury, and hypotension, as defined in the study protocol. Performance will be evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity.
Time frame: mSSS assessed at emergency department presentation; syndrome-specific core outcomes assessed through 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jul 2027, 25 months after the start.
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Jubilee Mission Medical College and Research Institute