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CTRI Number  CTRI/2024/08/073073 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Pre-Hospital Snakebite Treatment:Analysis from the VENOMS Registry 
Scientific Title of Study   Pre-hospital interventions in snakebite: A sub analysis of VENOMS registry 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Usha 
Designation  Postgraduate student  
Affiliation  Manipal College of Health Professions MAHE Manipal 
Address  Department of Emergency Medical Technology Manipal College of Health Professions MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9632811362  
Fax    
Email  ushawagle2407@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Freston Marc Sirur 
Designation  Associate Professor 
Affiliation  Kasturba Medical College and Hospital MAHE Manipal  
Address  Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9604200840  
Fax    
Email  freston.sirur@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Freston Marc Sirur 
Designation  Associate Professor 
Affiliation  Kasturba Medical College and Hospital MAHE Manipal  
Address  Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal


KARNATAKA
576104
India 
Phone  9604200840  
Fax    
Email  freston.sirur@manipal.edu  
 
Source of Monetary or Material Support  
Department of Emergency Medicine Kasturba Medical College and Hospital Manipal Academy of Higher Education Manipal Udupi Karnataka India- 576104 
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital 
Address  Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Madhava Nagar Manipal Udupi Karnataka India 576104 
Type of Sponsor  Other [Research Institution and Medical College ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Freston Marc Sirur  Kasturba Medical College and Hospital Manipal  Department of Emergency Medicine Kasturba Medical College and Hospital Manipal Academy of Higher Education Manipal 576104 Karnataka India
Udupi
KARNATAKA 
9604200840

freston.sirur@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medial College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients who had presented to Emergency Department Kasturba Medical College and Hospitals MAHE Manipal with history of snakebite between 01 August 2019 to 31 July 2024 
 
ExclusionCriteria 
Details  All envenomation that are confirmed not from snakebite
All animal Bites
All marine envenomation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of snakebite patients receiving medical pre-hospital interventions
 
At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of snakebite patients receiving non-medical pre-hospital interventions.
To describe challenges faced in delivering pre-hospital interventions in snakebite Geospatial mapping of high-risk areas using QGIS software
Identification primary and pre-hospital network for training and upskilling for
wilderness/snakebite management
Correlation of medical and non-medical interventions with mortality
Correlation with morbidity
7.



Evaluating the incidence of complications of pre-hospital interventions used in snakebite
Correlation of pre-admission ASV administration with outcome (morbidity and mortality)
Correlation of pre-hospital interventions with patient stability on arrival 
At baseline 
 
Target Sample Size   Total Sample Size="662"
Sample Size from India="662" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The collection of data shall be initiated after obtaining approval from the institutional ethics committee and CTRI Registration. All cases of Snakebite shall be collected from the VENOMS registry from 01 August 2019 to 31 July 2024. The VENOMS Registry is a CTRI registered single centric hospital-based registry that includes all cases of envenomation presenting at the ED (CTRI/2019/10/021828). 
PHASE 1: Retrospective analysis of all the patients who had presented with the history of snakebite to the Emergency Department, Kasturba Medical College Manipal, MAHE, between 01 August 2019 to 31 July 2024. Pre-hospital and peripheral Centre interventions in snakebite will be recorded from the VENOMS Registry and Medical Records Department (MRD). 
PHASE 2: Telephonic interview will be done to gather additional information that were not a part of the venoms registry by obtaining verbal consent as per the proforma for phase 2. Contact numbers of the participants will be obtained through the Medical Records Department (MRD). We will ask the responder if they were present when the incident happened. If yes, then a verbal consent would be obtained according to the Telephonic consent format, and the Phase 02 questionnaire will be delivered. The interview will not last longer than 30-minutes. If the responder was not present during the incident, the interviewee will be asked to direct to the person who was aware or present during the incident. Their contact will be collected, verbal telephonic consent will be obtained, and the questionnaire will be delivered according to the Phase 02 proforma. An attempt will be made to contact them in-person, if within the same district. Knowledge attitude, current-status and data gaps may be collected. As part of participating in this study, all participants will receive a brief health education session over the telephone. This session will provide crucial information on how to respond to a snakebite, including immediate measures to take and guidance on safely transporting the victim to the medical facility. Any questions participants may have regarding snakebites will be thoroughly addressed during the telephone interview. Statistical analysis will be done using descriptive statistics and inferential statistics. Geospatial mapping will be done by using QGIS software. 
 
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