Hemostatic Variables In Snakebite Study
HISS
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
2 other identifiers
observational
96
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2023
CompletedMarch 7, 2024
March 1, 2024
1.4 years
May 31, 2020
March 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
up to 30 days
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).
up to 30 days
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).
up to 30 days
Secondary Outcomes (6)
Diagnostic accuracy of Clotting Time in detecting coagulopathy
48 hours
Diagnostic accuracy of 20'WBCT, MLW, Delayed reading of 20'WBCT in detecting coagulopathy
48 hours
Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation of the bedside coagulation tests.
48 hours
Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation conventional coagulation tests
48 hours
To study the serial change in PT and aPTT-clot waveform of snakebite victims
up to 7 days
- +1 more secondary outcomes
Other Outcomes (11)
Time to envenomation in hematotoxic snakebites in the region
7 days
Time to envenomation in Russells viper snake bite in the region
48 hours
Time to envenomation in pitviper (crotaline) snake bite in the region
48 hours
- +8 more other outcomes
Eligibility Criteria
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
You may qualify if:
- All patients with history suggestive of snakebite presenting within 6 hours of snakebite AND
- All providing a written informed consent and/or assent
You may not qualify if:
- 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-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005, India
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: 30429630BACKGROUND
Biospecimen
Blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siju V Abraham, M D
Jubilee Mission Medical College and Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 31, 2020
First Posted
August 20, 2020
Study Start
March 15, 2022
Primary Completion
July 31, 2023
Study Completion
August 9, 2023
Last Updated
March 7, 2024
Record last verified: 2024-03