AzTrials
AzTrials

Snake BitesHISSNCT04520282

Hemostatic Variables In Snakebite Study

An observational study of Snake Bites and Coagulopathy, Consumption, run by Jubilee Mission Medical College and Research Institute at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background Novelty The global assays of coagulation, namely the viscoelastometric tests and clot waveform has never been studied in detail before in snakebite victims. The pathophysiology of VICC including specific factor deficiencies and serial trend in blood cell indices amongst various hematotoxic snakebite in the… Read more about this study

Who is it for?
Any age
Conditions the study is for
Snake Bites, Coagulopathy, Consumption
How many people
96 participants
Where
1 siteIndia
Study dates
15 Mar 2022to 9 Aug 2023
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 patients with history suggestive of snakebite presenting within 6 hours of snakebite and providing a written informed consent and/or assent would be included in the study Definitions: 'Snakebite' OR 'History suggestive of snakebite' would be defined as, patients or their bystander claiming in sound mind not and not under the influence of any inebriants, to have witnessed being bitten by a snake, OR, patient with clinical features of snakebite as suspected by the clinician on floor

Who may be able to join

  • All patients with history suggestive of snakebite presenting within 6 hours of snakebite AND
  • All providing a written informed consent and/or assent

Who cannot join

  • All patients of stings or bites other than snakes
  • All patients who received antivenom or blood products at another institute
  • All patients with known hematological malignancies, coagulation disorders, chronic liver or renal failure.
  • All patients known to be on warfarin, heparin or any newer oral or injectable anticoagulants
  • All withdrawing a consent later on, or withdrawing assent later on-

Trial locations and contacts

1 site in 1 country.

India1 site
  • Jubilee Mission Medical College and Research Institute

    Thrissur, Kerala, 680005

Other trials in India

About this study

Official title: Haemostatic Variables in Snakebite: a Regional Prospective Cohort to Identify the Role of Global Coagulation Assays and Serial Laboratory Testing in the Management of Snakebite Coagulopathy

Background

Novelty The global assays of coagulation, namely the viscoelastometric tests and clot waveform has never been studied in detail before in snakebite victims.

The pathophysiology of VICC including specific factor deficiencies and serial trend in blood cell indices amongst various hematotoxic snakebite in the region is not known.

No Indian study to date has systematically examined the changes in early laboratory tests results in envenomed and non envenomed snakebite victims.

Read the detailed description

The problem:

Snakebite is a neglected disease of the poor in India. Nearly 50,000 individuals die of snake bite every year in the country, making it the region with most number of snakebite related deaths in the world.

Snakebite though is one of the leading cause of mortality and morbidity globally, it is in fact a "local" problem which warrants a regionalized approach. The venom characteristics of snakes and their response to treatment vary across geographical regions, even within the same species.

Therefore the venom sourcing for antivenom production, to clinical characterization of snakebites needs to be regionalized.

Clinical profiling of snakebite has been done in many observational studies across the region but a comprehensive prospective regional profiling of laboratory parameters including the global assays have not been done to date.

The health care in India is mostly out of one's own pocket, and the victims are of the lower socio economic strata the health care costs are seldom affordable. Research in the field is also sparse due to lack of funding for the same. The investigators through this research aim to study the clinical and laboratory profile of snakebite victims presenting to a tertiary care snakebite treatment centre in central Kerala and the role of global coagulation assays in the management of the same.

Once answered, the research question, would provide a better understanding of the hematotoxic snakebite in the region.

It could aid in better patient care strategies, including possible determination of a better test for coagulopathy, judicious antivenom and blood product usage.

Its relevance in local, national and international context:.

Snakebite being region specific warrants a region specific approach to the problem. Venomous species like Humpnosed pit viper (Hypnale hypnale) envenomation which is the second most common snakebite (first being Daboia russelli ) in the region is a serious problem that needs better understanding.

This would be a model which can be replicated in selected tertiary care snakebite centers across the country. Answering these research questions across the country would lead to better understanding of coagulopathy in snakebite, its response to antivenom and blood products in India.

It may also lead to quantifying the need for region specific antivenom in the country.

No Indian study has systematically examined the changes in early laboratory tests results in envenomed and non envenomed snakebite victims to date.

With the exception of a few case reports there has been no studies that has looked at the performance of global coagulation assays in the country.

The country that becomes the largest contributor of global burden of snake bite in terms of mortality is India.

This model if applicable in India, should be replicable elsewhere too. Ten years back, the investigators would not have been able to envision this study, since the understanding of the process of snake bite related coagulopathy was limited, and it was national projects like the Australian snake bite project implemented elsewhere that form the basis for the current understanding of the problem of snakebite.

In the international context many other low and middle income countries that are burdened by snake bites would benefit from any result in terms of a better bedside coagulation test (like CWA or MLW) or a cheaper blood indices (DNI) to prognosticate snake envenomation.

The understanding of coagulopathy in snakebite is now changing. Conventionally, although this coagulopathy is likened to disseminated intravascular coagulation (DIC), in the recent years, it has been described as venom-induced consumptive coagulopathy (VICC).

VICC defers from DIC in its rapidity of both onset and resolution. It used to be compared to Disseminated Intravascular Coagulation, but now the understanding of the same is changing and more recently the term VICC- Venom induced consumptive coagulopathy has been introduced. The snake venom in India are known to contain Factor V activators (D russelli), Factor X activators (D russelli), prothrombin activators (PTA) (Echis sp.), thrombin like enzymes (TLE) and fibrinogenases (Trimeresurus sp,. Hypnale hypnale). The above mentioned findings are mostly from studies in Srilanka, with assays done in samples frozen and sent to Australia, by the same team of investigators.

There are not many properly conducted study from any region of India that helps understand the pathophysiology better.

Keywords
global coagulation assay, hemostatic variables, coagulopathy, VICC, DIC, Venom induced consumptive coagulopathy, Disseminated intravascular coagulation, ROTEM, CWA, clot waveform analysis, 20'WBCT, Clotting time, thromboelastometry, viscoelastometry, blood cell indices, snakebite, hematotoxic
Medical subject headings
Snake Bites, Disseminated Intravascular Coagulation, Hemostatic Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To study the serial change in CT of snakebite victims

    Change from baseline (sample taken at admission) for clotting time would be recorded in minutes and seconds assessed at 1 hour (post admission), 1 hour 30 mins (post admission), 3 hours (post admission), 6 hours (post bite), 6 hours post antivenom, 6 hours after blood products or 12 hours after antivenom and at discharge or at 30 days (whichever is earlier)

    Measured: up to 30 days

  2. To study the serial change in fibrinogen levels of snakebite victims

    The change in fibrinogen levels from baseline (sample taken at admission, 0 hour), 6 hour post bite, 6 hours post antivenom,12 hours post antivenom, 6 hours after blood products and at discharge or at 30 days (whichever occurs earlier), measured in weight per volume (milligram per decilitre).

    Measured: up to 30 days

  3. To study the serial change in D dimer levels of snakebite victims

    The change D dimer from baseline (sample taken at admission, 0 hour), 6 hour post bite, 6 hours post antivenom,12 hours post antivenom, 6 hours after blood products and at discharge or at 30 days (whichever occurs earlier) measured in weight per volume ( micrograms per decilitre respectively).

    Measured: up to 30 days

Secondary outcomes (6)
  1. Diagnostic accuracy of Clotting Time in detecting coagulopathy

    Sensitivity and specificity of Clotting Time (minutes) done using Modified Lee and White method (MLW) in detecting coagulopathy compared to conventional coagulation test (PT, aPTT)

    Measured: 48 hours

  2. Diagnostic accuracy of 20'WBCT, MLW, Delayed reading of 20'WBCT in detecting coagulopathy

    Sensitivity, specificity of

    1. 20'WBCT (minutes)
    2. Delayed reading of 20'WBCT (30'WBCT) in detecting coagulopathy compared to conventional coagulation test (PT, aPTT)

    Measured: 48 hours

  3. Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation of the bedside coagulation tests.

    Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation of bedside coagulation tests (20'WBCT, MLW Clotting time, Delayed reading of 20'WBCT, Activated Clotting Time) (before and after antivenom)

    Measured: 48 hours

  4. Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation conventional coagulation tests

    Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation of conventional coagulation tests PT/INR and aPTT (before and after antivenom)

    Measured: 48 hours

  5. To study the serial change in PT and aPTT-clot waveform of snakebite victims

    The change of PT and aPTT-clot waveform from baseline (sample taken at admission; 0 Hours) would be recorded in milli absorption (mabs) per second, 6 hours (post bite), 6 hours post antivenom, 12 hours post antivenom ,6 hours after blood products and at discharge or 7 days whichever is earlier

    Measured: up to 7 days

  6. To describe the clinical characteristics of snakebite victims measured as per a pre set proforma

    The clinical characteristics of snakebite victims, including systemic manifestation and local manifestations would be measured as per a pre set proforma

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start15 Mar 2022
  3. Primary completion31 Jul 2023
  4. Study completion9 Aug 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04520282
Sponsor's protocol ID
01/20/IEC/JMMC&RI
Other IDs
U1111-1252-7998
Acronym
HISS
Status last verified
Mar 2024
First submitted
31 May 2020
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30429630

Questions about this trial

What is this clinical trial studying?

An observational study of Snake Bites and Coagulopathy, Consumption, run by Jubilee Mission Medical College and Research Institute 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 7 Mar 2024. 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?

To study the serial change in CT of snakebite victims (time frame: up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520282, which also lists 1 linked publication.

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 7 Mar 2024.

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