Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test in Snakebite Victims
LAT
Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims
2 other identifiers
observational
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 17, 2020
August 1, 2020
1.1 years
March 22, 2019
August 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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)
48 hours
Secondary Outcomes (4)
Sensitivity of admission 20'WBCT and MLW to diagnose Russells viper (Daboia ruselli) envenomation
48hours
Sensitivity of admission 20'WBCT and MLW to diagnose Hump-nosed pit viper (Hypnale hypnale) envenomation
48hours
Time to detection of hematotoxic envenomation in MLW and 20'WBCT
48 hours
Sensitivity and specificity of delayed reading of clotting time and clotting test at 30 minutes in detecting coagulopathy
48 hours
Study Arms (1)
snakebite victims
Victims of snakebite presenting to the Emergency Department of Jubilee Mission Medical College and Research Institute
Interventions
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.
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.
Eligibility Criteria
All snake bite victims presenting to the emergency department of Jubilee mission medical college and research institute.
You may qualify if:
- All victims of snake bite presenting to the emergency department AND
- Consenting to be part of the study
You may not qualify if:
- Those not providing a written informed consent OR
- Those on anticoagulants or antiplatelets OR
- With a known hematological disorder OR
- A known history of chronic liver disease OR
- Received antivenom or blood products following snakebite at another centre
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Appu Suseellead
Study Sites (1)
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Siju Varghese Abraham, M.D
Jubilee Mission Medical College and Research Institute
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 22, 2019
First Posted
March 26, 2019
Study Start
May 1, 2019
Primary Completion
May 31, 2020
Study Completion
June 30, 2020
Last Updated
August 17, 2020
Record last verified: 2020-08