Viewing Study NCT03890016



Ignite Creation Date: 2024-05-06 @ 12:57 PM
Last Modification Date: 2024-10-26 @ 1:06 PM
Study NCT ID: NCT03890016
Status: COMPLETED
Last Update Posted: 2020-08-17
First Post: 2019-03-22

Brief Title: Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test in Snakebite Victims
Sponsor: Appu Suseel
Organization: Jubilee Mission Medical College and Research Institute

Study Overview

Official Title: Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims
Status: COMPLETED
Status Verified Date: 2020-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LAT
Brief Summary: 20 minute Whole Blood Clotting Test20WBCT recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country

The Modified Lee and White MLW method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the 20WBCT

The investigators propose that delayed reading of both MLW and 20WBCT to check for clot stability at 30 minutes also provides added information in management of snake bite victims
Detailed Description: Envenomation by snakes is common in India Hematotoxic bites cause the highest morbidity and mortality in Kerala a state in the south of India

20 minute Whole Blood Clotting Test20WBCT recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country It is the tool of choice due to its cost effectiveness in low and middle income countries LMIC

The reliability of 20WBCT is questionable with respect to not just its rapidity but also its reliability There is no standardisation for the test and procedure

Modified Lee White MLW Method for coagulation is a cheap bed side test used as part of the standard treatment protocol of snake bite victims The MLW method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the World Health Organisation recommended 20WBCT

The investigators also propose that delayed reading of both MLW and 20WBCT to check for clot stability also provides added information in management of snake bite victims

The bed side coagulation test done forms the trigger to commence antivenom in snake bite victims with hematotoxicity in resource limited settings

Lee White MLW Method for coagulation is a test that has been employed for decades to assess coagulation in Jubilee Mission Hospital Medical College and Research Institute in Thrissur for snake bite victims It is a cheap bed side test used as part of the standard treatment protocol of snake bite victims The MLW method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the World Health Organisation recommended 20WBCT

The investigators also propose that delayed reading of both MLW and 20WBCT to check for clot stability or clot lysis also provides added information in management of snake bite victims

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U1111-1228-5286 OTHER World Health Organisation None