Snake BiteSCOPE-SnakeNCT07079137
Predictive Accuracy of the Snakebite Severity Score (SSS) in Identifying Syndrome-Specific Core Outcome Parameters Among Envenomated Patients Presenting to the Emergency Department
An observational study of Snake Bite, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snake Bite
- What is being tested?
- History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- 14 Jun 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- All patients 'clinically suspected snakebite'
- Presenting within 24 hours of the event
- Age ≥18 years
- Providing written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Jubilee Medical Mission and Research Institute
Thrissur, Kerala, 680005
Siju Varghese Associate Professor, MD Emergency Medicine, 9447754321, sijuvabraham@gmail.com
About this study
Official title: A Prospective 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.
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.
Read more
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.
- Conditions
- Snake Bite
- Being tested
- History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol
- Keywords
- snakebite, antivenom, snakebite severety score, modified snakebite severety score
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocolOther
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
| Study group | Role | What they receive |
|---|---|---|
| ● All patients 'clinically suspected snakebite' ● Presenting within 24 hours of the event ● Age ≥ | Not described Receives: Other: History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: SSS assessed at emergency department presentation; syndrome-specific core outcomes assessed from presentation through 30 days
Secondary outcomes (2)
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).
Measured: 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.
Measured: mSSS assessed at emergency department presentation; syndrome-specific core outcomes assessed through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start14 Jun 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake BiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Feba Susan Kurian, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079137
- Sponsor's protocol ID
- 67/25/IEC/JMMC&RI
- Other IDs
- U1111-1324-5906
- Acronym
- SCOPE-Snake
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective 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.
- ClinicalTrials.gov ID
- NCT07079137
- Acronym / sponsor ID
- SCOPE-Snake / 67/25/IEC/JMMC&RI
- Conditions
- Snake Bite
- Keywords
- snakebite, antivenom, snakebite severety score, modified snakebite severety score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ● All patients 'clinically suspected snakebite' ● Presenting within 24 hours of the event ● Age ≥ | – | Other: History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- All patients 'clinically suspected snakebite'
- Presenting within 24 hours of the event
- Age ≥18 years
- Providing written informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| History, examination, bite documentation, SSS scoring,Baseline labs as per institutional protocolFollowing 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 | Other | ● All patients 'clinically suspected snakebite' ● Presenting within 24 hours of the event ● Age ≥ |
Primary outcome
Performance of the Snakebite Severity Score (SSS) at Emergency Department Presentation in Predicting Syndrome-Specific Core Outcomes
Time frame: SSS assessed at emergency department presentation; syndrome-specific core outcomes assessed from presentation through 30 days
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).
2 secondary outcomes
Performance of the Snakebite Severity Score (SSS) at Emergency Department Presentation in Predicting All-Cause Mortality Within 6 Weeks
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
Time frame: mSSS assessed at emergency department presentation; syndrome-specific core outcomes assessed through 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Snake Bite, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feba Susan Kurian, MBBS (919061984552, febasusankurian1999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the Snakebite Severity Score (SSS) at Emergency Department Presentation in Predicting Syndrome-Specific Core Outcomes (time frame: SSS assessed at emergency department presentation; syndrome-specific core outcomes assessed from presentation through 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.