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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To study the serial change in CT of snakebite victims
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with history suggestive of snakebite presenting within 6 hours of snakebite AND
- •All providing a written informed consent and/or assent
排除标准
- •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-
结局指标
主要结局
To study the serial change in CT of snakebite victims
时间窗: up to 30 days
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)
To study the serial change in D dimer levels of snakebite victims
时间窗: up to 30 days
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).
To study the serial change in fibrinogen levels of snakebite victims
时间窗: up to 30 days
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).
次要结局
- 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 conventional coagulation tests(48 hours)
- To describe the clinical characteristics of snakebite victims measured as per a pre set proforma(up to 30 days)
- Diagnostic accuracy of Clotting Time in detecting coagulopathy(48 hours)
- To study the serial change in PT and aPTT-clot waveform of snakebite victims(up to 7 days)
- Change in coagulopathy in snakebite victims, after antivenom administration as measured by normalisation of the bedside coagulation tests.(48 hours)
研究者
Siju V Abraham, MD
Associate Professor
Jubilee Mission Medical College and Research Institute