Waveform Analysis In Snakebite Victims With Hematotoxicity

NCT03859154 | Completed

• 2 other identifiers: 05/19/IEC/JMMC&RIU1111-1229-0385
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Snakebite; Coagulopathy, Consumption

Outcome Measures

Primary Outcomes (3)

• Clot wave form 1st derivative changes

  Changes in the 1 st derivative

  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.

• Clot wave form 2nd derivative changes

  Changes in the 2nd derivative

  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 delay phase, baseline, acceleration, deceleration and end point phases of CWA

  Changes in the predefined Clot wave segments

  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.

Secondary Outcomes (2)

• Clotting time (CT)

  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..

• maximum coagulation velocity

  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.

Other Outcomes (2)

• sensitivity and specificity of CWA in detecting envenomation compared to 20'WBCT and MLW (Modified Lee and White) method

  from admission till time of objective detection of coagulopathy, or up to 48 hours of admission, whichever is earliest

• correlation of CWA with serum fibrinogen levels

  For all serum Fibrinogen and aPTT sample sent simultaneously upto 48 hours of admission.

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 686012, India

Location

Related Publications (1)

• Abraham SV, Rafi AM, Krishnan SV, Palatty BU, Innah SJ, Johny J, Varghese S. Utility of Clot Waveform Analysis in Russell's Viper Bite Victims with Hematotoxicity. J Emerg Trauma Shock. 2018 Jul-Sep;11(3):211-216. doi: 10.4103/JETS.JETS_43_17.

  PMID: 30429630 RESULT

MeSH Terms

Conditions

Snake Bites; Disseminated Intravascular Coagulation

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Thrombophilia

Study Officials

• Siju V Abraham, M.D

  Jubilee Mission Medical College and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Department of Emergency Medicine

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: March 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

IN (1)