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临床试验/NCT03890016
NCT03890016已完成不适用

Comparing Modified Lee White Method Against 20 Minute Whole Blood Clotting Test as a Bedside Coagulation Test in Snake Envenomation Victims

Appu Suseel1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
Sensitivity and specificity of serial Modified Lee White Method(MLW) in comparison with twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims.

研究概览

简要总结

20 minute Whole Blood Clotting Test(20'WBCT) recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country.

The Modified Lee and White (MLW) method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the 20'WBCT.

The investigators propose that delayed reading of both MLW and 20'WBCT to check for clot stability at 30 minutes also provides added information in management of snake bite victims.

详细描述

Envenomation by snakes is common in India. Hematotoxic bites cause the highest morbidity and mortality in Kerala, a state in the south of India.

20 minute Whole Blood Clotting Test(20'WBCT) recommended by World Health Organisation guidelines is probably the most routinely employed bed side screening tool in the country. It is the tool of choice due to its cost effectiveness in low and middle income countries (LMIC).

The reliability of 20'WBCT is questionable with respect to not just its rapidity but also its reliability. There is no standardisation for the test and procedure.

Modified Lee White (MLW) Method for coagulation is a cheap bed side test used as part of the standard treatment protocol of snake bite victims. The MLW method gives a value which when performed serially gives a trend in clotting time which the investigators hypothesise to be a better tool in serially assessing the victim compared to the World Health Organisation recommended 20'WBCT.

The investigators also propose that delayed reading of both MLW and 20'WBCT to check for clot stability also provides added information in management of snake bite victims.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All victims of snake bite presenting to the emergency department AND
  • Consenting to be part of the study

排除标准

  • Those not providing a written informed consent OR
  • Those on anticoagulants or antiplatelets OR
  • With a known hematological disorder OR
  • A known history of chronic liver disease OR
  • Received antivenom or blood products following snakebite at another centre

结局指标

主要结局

Sensitivity and specificity of serial Modified Lee White Method(MLW) in comparison with twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims.

时间窗: 48 hours of snakebite

Sensitivity and Specificity of admission Modified Lee White Method(MLW) and twenty minute Whole Blood Clotting Test in detecting coagulopathy in snakebite victims.

时间窗: 48 hours

Comparing MLW and 20'WBCT to gold standard tests like Prothrombin Time (PT) and activated partial thromboplastin time (aPTT)

次要结局

  • Time to detection of hematotoxic envenomation in MLW and 20'WBCT(48 hours)
  • Sensitivity of admission 20'WBCT and MLW to diagnose Russells viper (Daboia ruselli) envenomation(48hours)
  • Sensitivity of admission 20'WBCT and MLW to diagnose Hump-nosed pit viper (Hypnale hypnale) envenomation(48hours)
  • Sensitivity and specificity of delayed reading of clotting time and clotting test at 30 minutes in detecting coagulopathy(48 hours)

研究者

发起方
Appu Suseel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Appu Suseel

Assistant Professor

Jubilee Mission Medical College and Research Institute

研究点 (1)

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