Clinical trial NCT03890016: Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test in Snakebite Victims
Official title: Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Defect
Snake Bites
Keywords: Modified Lee and White Method
20'WBCT
Whole Blood Clotting Test
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All snake bite victims presenting to the emergency department of Jubilee mission medical college and research institute.

Brief summary: 20 minute Whole Blood Clotting Test(20'WBCT) 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 20'WBCT.

The investigators propose that delayed reading of both MLW and 20'WBCT 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 Test(20'WBCT) 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 20'WBCT 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 20'WBCT.

The investigators also propose that delayed reading of both MLW and 20'WBCT 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 20'WBCT.

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

Eligibility criteria: Inclusion Criteria:

1. All victims of snake bite presenting to the emergency department AND
2. Consenting to be part of the study

Exclusion Criteria:

1. Those not providing a written informed consent OR
2. Those on anticoagulants or antiplatelets OR
3. With a known hematological disorder OR
4. A known history of chronic liver disease OR
5. Received antivenom or blood products following snakebite at another centre

Primary outcomes:
measure: Sensitivity and specificity of serial Modified Lee White Method(MLW) in comparison with twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims.
timeFrame: 48 hours of snakebite
measure: Sensitivity and Specificity of admission Modified Lee White Method(MLW) and twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims.
timeFrame: 48 hours
Secondary outcomes:
measure: Sensitivity of admission 20'WBCT and MLW to diagnose Russells viper (Daboia ruselli) envenomation
timeFrame: 48hours
measure: Sensitivity of admission 20'WBCT and MLW to diagnose Hump-nosed pit viper (Hypnale hypnale) envenomation
timeFrame: 48hours
measure: Time to detection of hematotoxic envenomation in MLW and 20'WBCT
timeFrame: 48 hours
measure: Sensitivity and specificity of delayed reading of clotting time and clotting test at 30 minutes in detecting coagulopathy
timeFrame: 48 hours
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College and Research Institute
state: Kerala
Study officials:
affiliation: Jubilee Mission Medical College and Research Institute
name: Siju Varghese Abraham, M.D
role: STUDY_DIRECTOR
References: