Coagulation DefectLATNCT03890016
Study Comparing Modified Lee White Clotting Time Against Twenty Minute Whole Blood Clotting Test in Snakebite Victims
An observational study of Coagulation Defect and Snake Bites, run by Appu Suseel at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coagulation Defect, Snake Bites
- What is being tested?
- 20'Whole Blood ClottingTest (WBCT) and Modified Lee and White (MLW) Method Clotting Time
- Type of treatment
- Injection or infusion
- How many people
- 230 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2019to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All snake bite victims presenting to the emergency department of Jubilee mission medical college and research institute.
Who may be able to join
- All victims of snake bite presenting to the emergency department AND
- Consenting to be part of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005
About this study
Official title: Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims
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.
Read the 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.
- Conditions
- Coagulation Defect, Snake Bites
- Being tested
- 20'Whole Blood ClottingTest (WBCT), Modified Lee and White (MLW) Method Clotting Time
- Keywords
- Modified Lee and White Method, 20'WBCT, Whole Blood Clotting Test
- Medical subject headings
- Hemostatic Disorders, Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20'Whole Blood ClottingTest (WBCT)Diagnostic test
Also called 20'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.
Modified Lee and White (MLW) Method Clotting TimeDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| snakebite victims | Victims of snakebite presenting to the Emergency Department of Jubilee Mission Medical College and Research Institute Receives: Diagnostic Test: 20'Whole Blood ClottingTest (WBCT); Diagnostic Test: Modified Lee and White (MLW) Method Clotting Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 48 hours
Secondary outcomes (4)
Sensitivity of admission 20'WBCT and MLW to diagnose Russells viper (Daboia ruselli) envenomation
Measured: 48hours
Sensitivity of admission 20'WBCT and MLW to diagnose Hump-nosed pit viper (Hypnale hypnale) envenomation
Measured: 48hours
Time to detection of hematotoxic envenomation in MLW and 20'WBCT
Measured: 48 hours
Sensitivity and specificity of delayed reading of clotting time and clotting test at 30 minutes in detecting coagulopathy
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 May 2019
- Primary completion31 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appu Suseel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Appu Suseel, Jubilee Mission Medical College and Research Institute
- Investigators
- Siju Varghese Abraham, M.D, Study director, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890016
- Sponsor's protocol ID
- 01/19/IEC/JMMC&RI
- Other IDs
- U1111-1228-5286
- Acronym
- LAT
- Status last verified
- Aug 2020
- First submitted
- 22 Mar 2019
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims
- ClinicalTrials.gov ID
- NCT03890016
- Acronym / sponsor ID
- LAT / 01/19/IEC/JMMC&RI
- Conditions
- Coagulation Defect, Snake Bites
- Keywords
- Modified Lee and White Method, 20'WBCT, Whole Blood Clotting Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Appu SuseelUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| snakebite victims | – | Diagnostic Test: 20'Whole Blood ClottingTest (WBCT), Diagnostic Test: Modified Lee and White (MLW) Method Clotting TimeVictims of snakebite presenting to the Emergency Department of Jubilee Mission Medical College and Research Institute |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All snake bite victims presenting to the emergency department of Jubilee mission medical college and research institute.
Key inclusion criteria (2 listed)
- All victims of snake bite presenting to the emergency department AND
- Consenting to be part of the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20'Whole Blood ClottingTest (WBCT)Also: 20'WBCT1ml 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. | Diagnostic test | snakebite victims |
| Modified Lee and White (MLW) Method Clotting TimeThe 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. | Diagnostic test | snakebite victims |
Primary outcome
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.
Time frame: 48 hours
Comparing MLW and 20'WBCT to gold standard tests like Prothrombin Time (PT) and activated partial thromboplastin time (aPTT)
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siju Varghese Abraham, M.D study director
Jubilee Mission Medical College and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Defect and Snake Bites, run by Appu Suseel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 48 hours of snakebite). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.