Hemostatic Variables In Snakebite Study — HISS  

Snake Bites Clinical Trial

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

Status Completed

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy, Consumption
• Disseminated Intravascular Coagulation
• Hemostatic Disorders
• Snake Bites

• NCT number: NCT04520282
• Study type: Observational
• Source: Jubilee Mission Medical College and Research Institute
• Status: Completed
• Start date: March 15, 2022
• Completion date: August 9, 2023