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Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test in Snakebite Victims (LAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890016
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Appu Suseel, 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.


Condition or disease Intervention/treatment
Coagulation Defect Snake Bites Diagnostic Test: 20'Whole Blood ClottingTest (WBCT) Diagnostic Test: Modified Lee and White (MLW) Method Clotting Time

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.

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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
snakebite victims
Victims of snakebite presenting to the Emergency Department of Jubilee Mission Medical College and Research Institute
Diagnostic Test: 20'Whole Blood ClottingTest (WBCT)

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.

Other Name: 20'WBCT

Diagnostic Test: Modified Lee and White (MLW) Method Clotting Time

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.





Primary Outcome Measures :
  1. 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 ]
  2. Sensitivity and Specificity of admission Modified Lee White Method(MLW) and twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims. [ Time Frame: 48 hours ]
    Comparing MLW and 20'WBCT to gold standard tests like Prothrombin Time (PT) and activated partial thromboplastin time (aPTT)


Secondary Outcome Measures :
  1. Sensitivity of admission 20'WBCT and MLW to diagnose Russells viper (Daboia ruselli) envenomation [ Time Frame: 48hours ]
  2. Sensitivity of admission 20'WBCT and MLW to diagnose Hump-nosed pit viper (Hypnale hypnale) envenomation [ Time Frame: 48hours ]
  3. Time to detection of hematotoxic envenomation in MLW and 20'WBCT [ Time Frame: 48 hours ]
  4. Sensitivity and specificity of delayed reading of clotting time and clotting test at 30 minutes in detecting coagulopathy [ Time Frame: 48 hours ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All snake bite victims presenting to the emergency department of Jubilee mission medical college and research institute.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890016


Locations
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India
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, India, 680005
Sponsors and Collaborators
Appu Suseel
Investigators
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Study Director: Siju Varghese Abraham, M.D Jubilee Mission Medical College and Research Institute
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Responsible Party: Appu Suseel, Assistant Professor, Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier: NCT03890016    
Other Study ID Numbers: 01/19/IEC/JMMC&RI
U1111-1228-5286 ( Other Identifier: World Health Organisation )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Appu Suseel, Jubilee Mission Medical College and Research Institute:
Modified Lee and White Method
20'WBCT
Whole Blood Clotting Test
Additional relevant MeSH terms:
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Thrombosis
Hemostatic Disorders
Blood Coagulation Disorders
Snake Bites
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Hematologic Diseases
Hemorrhagic Disorders