An observational study in Coagulation Defect and Snake Bites, sponsored by Appu Suseel. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2020-08-17.
Sponsored by Appu Suseel · Observational
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.
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.
361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.
This study's enrollment of 230 is above the median of 120 across 174 observational studies indexed under Hemostatic Disorders.
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All snake bite victims presenting to the emergency department of Jubilee mission medical college and research institute.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Victims of snakebite presenting to the Emergency Department of Jubilee Mission Medical College and Research Institute
Diagnostic Test: 20'Whole Blood ClottingTest (WBCT) · Diagnostic Test: Modified Lee and White (MLW) Method Clotting Time
1ml of blood drawn from snake bite victims in clean glass test tubes of 1 cm diameter Kept undisturbed for a period of 20 minutes (measured by a stop watch). At the end of 20 minutes the tube is tilted to see if the blood has clotted or not. If a well formed clot is not formed, the test is recorded as 'abnormal'. If the clot seems well formed, it is further observed for a period of 30 minutes to look for dissolution of the formed clot and would be termed "clot lysis". Clot lysis indicates an unstable clot.
Also known as: 20'WBCT
The blood collected in three additional test tubes would be utilised for MLW. The three test tubes would be kept on a rack at ambient temperature. The blood sample would be drawn in a 5cc syringe and 1 ml would be added in the three test tubes consecutively. The test tube would be left undisturbed for 5 minutes, after that the first tube would be tilted approximately to check for clot formation every 30 seconds while the other tubes are left undisturbed. After the blood in the first tube has clotted, the time would be noted and the second tube would be tilted every 30 seconds and examined. Following its clotting, the third tube would be examined. The time at which the third tube is recorded as the CT value. Once clotted, then the sample in the all three test tube would be assessed at 20 minute and 30 min to look for breakup or lysis of the clot.
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.
Time frame: 48 hours of snakebite
Sensitivity and Specificity of admission Modified Lee White Method(MLW) and twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims.
Comparing MLW and 20'WBCT to gold standard tests like Prothrombin Time (PT) and activated partial thromboplastin time (aPTT)
Time frame: 48 hours
Sensitivity of admission 20'WBCT and MLW to diagnose Russells viper (Daboia ruselli) envenomation
Time frame: 48hours
Sensitivity of admission 20'WBCT and MLW to diagnose Hump-nosed pit viper (Hypnale hypnale) envenomation
Time frame: 48hours
Time to detection of hematotoxic envenomation in MLW and 20'WBCT
Time frame: 48 hours
Sensitivity and specificity of delayed reading of clotting time and clotting test at 30 minutes in detecting coagulopathy
Time frame: 48 hours
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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