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Waveform Analysis In Snakebite Victims With Hematotoxicity (WISH)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859154
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Siju V Abraham, MD, Jubilee Mission Medical College and Research Institute

Brief Summary:

In hematotoxic snakebites, due to the lack of a better alternative, 20 minute whole blood clotting test (20'WBCT) or Clotting time remains the standard test in developing countries even though its reliability and sensitivity has been shown to be low.

Activated partial thromboplastin time (aPTT) based Clot Waveform Analysis (CWA) is an optic absorbance assay that can be used as a global clotting test.

It essentially detects the change in colour of the plasma as coagulation progresses and quantifies the change in the form of a waveform.

In this study, the investigators intend to study prospectively the behaviour of clot wave (CW) in hematotoxic bites.

A pilot observational study was initially conducted (IEC Ref No. 42/16/IEC/JMMC and RI) and CWA showed changes which provided information earlier than the conventional coagulation studies in the snakebite victims studied.

While aPTT or WBCT reflects clotting time, CWA conveys the dynamic process of clot formation. CWA may reveal disorders of clotting in snakebite victims before the conventional tests become abnormal.

Here the investigators aim to study the changes in CWA in snakebite victims who develop coagulation disorders in blood


Condition or disease
Snakebite Coagulopathy, Consumption

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Waveform Analysis In Snakebite Victims With Hematotoxicity
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 31, 2021

Group/Cohort
Viper bite victims
Snakebite victims in whom the snake has been brought and positively identified as Viperidae AND simultaneous aPTT has been sent AND consenting to be part of the study
Nonvenomous snakebite

age and gender matched victims of snake bite in whom the culprit snake brought along has been identified as a non venomous one.

AND consenting to be part of the study




Primary Outcome Measures :
  1. Clot wave form 1st derivative changes [ Time Frame: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, upto 7 days post admission. ]
    Changes in the 1 st derivative

  2. Clot wave form 2nd derivative changes [ Time Frame: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission. ]
    Changes in the 2nd derivative

  3. changes in delay phase, baseline, acceleration, deceleration and end point phases of CWA [ Time Frame: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission. ]
    Changes in the predefined Clot wave segments


Secondary Outcome Measures :
  1. Clotting time (CT) [ Time Frame: For all CT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission.. ]
    The absolute clotting time by modified lee white method done for all samples as per institutional protocol

  2. maximum coagulation velocity [ Time Frame: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission. ]
    maximum coagulation velocity


Other Outcome Measures:
  1. sensitivity and specificity of CWA in detecting envenomation compared to 20'WBCT and MLW (Modified Lee and White) method [ Time Frame: from admission till time of objective detection of coagulopathy, or up to 48 hours of admission, whichever is earliest ]
    To test how sensitive and specific changes in CWA is in detecting coagulopathy in snakebite victims compared to the World Health Organisation Recommended twenty minute whole blood clotting test and the modified lee white clotting time done as per institute protocol

  2. correlation of CWA with serum fibrinogen levels [ Time Frame: For all serum Fibrinogen and aPTT sample sent simultaneously upto 48 hours of admission. ]
    For all serum Fibrinogen and aPTT sample sent simultaneously correlation of CWA parameters with serum fibrinogen levels



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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 victims of snakebite consenting to be part of the study presenting to the emergency department at Jubilee Mission Medical College and Research Institute Thrissur, Kerala, India

Snake bite registry would be established All consecutive cases would be enrolled in the study if they consent to be part of it.

Sub group analysis excluding the dry bites,would be done Sub group analysis of the victims of hematotoxic snakebite would be done

Criteria

Inclusion Criteria:

-snakebite victims were activated Partial Thromboplastin Time (aPTT) sample has been sent

Exclusion Criteria:

  • Not consenting to be part of the study
  • OR known case of coagulation disorders
  • OR chronic liver disease

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): NCT03859154


Contacts
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Contact: Siju V Abraham, M.D 919447754321 sijuvabraham@jmmc.ac.in

Locations
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India
Jubilee Mission Medical College and Research Institute Recruiting
Thrissur, Kerala, India, 686012
Contact: Siju Varghese Abraham, MD    +919447754311    sijuvabraham@gmail.com   
Sponsors and Collaborators
Jubilee Mission Medical College and Research Institute
Investigators
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Principal Investigator: Siju V Abraham, M.D Jubilee Mission Medical College and Research Institute
Publications of Results:
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Responsible Party: Siju V Abraham, MD, Assistant Professor in the Department of Emergency Medicine, Jubilee Mission Medical College and Research Institute
ClinicalTrials.gov Identifier: NCT03859154    
Other Study ID Numbers: 05/19/IEC/JMMC&RI
U1111-1229-0385 ( Other Identifier: World Health Organisation )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disseminated Intravascular Coagulation
Snake Bites
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Thrombophilia