| 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
|
|
|
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
|
|
|
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. |