Waveform Analysis In Snakebite Victims With Hematotoxicity
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
- changes in delay phase, baseline, acceleration, deceleration and end point phases of CWA
研究概览
简要总结
In hematotoxic snakebites, due to the lack of a better alternative, 20 minute whole blood clotting test (20'WBCT) or Clotting time remains the standard test in developing countries even though its reliability and sensitivity has been shown to be low.
Activated partial thromboplastin time (aPTT) based Clot Waveform Analysis (CWA) is an optic absorbance assay that can be used as a global clotting test.
It essentially detects the change in colour of the plasma as coagulation progresses and quantifies the change in the form of a waveform.
In this study, the investigators intend to study prospectively the behaviour of clot wave (CW) in hematotoxic bites.
A pilot observational study was initially conducted (IEC Ref No. 42/16/IEC/JMMC and RI) and CWA showed changes which provided information earlier than the conventional coagulation studies in the snakebite victims studied.
While aPTT or WBCT reflects clotting time, CWA conveys the dynamic process of clot formation. CWA may reveal disorders of clotting in snakebite victims before the conventional tests become abnormal.
Here the investigators aim to study the changes in CWA in snakebite victims who develop coagulation disorders in blood
详细描述
Viperidae bites are quite common in India and are notorious to cause hematotoxicity.
In hematotoxic bites, the test recommended to ascertain the development of coagulopathy is a whole blood clotting test (WBCT) as per the current guidelines.
Eventhough the reliability and sensitivity of WBCT has been shown to be low, it still remains the standard test.
There exists a need to explore other coagulation studies in snakebite to look for a better and efficient alternative.
Clot waveform analysis (CWA) is an activated partial thromboplastin time (aPTT)-based optic absorbance assay that can be used as a global clotting test.
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
- •snakebite victims were activated Partial Thromboplastin Time (aPTT) sample has been sent
排除标准
- •Not consenting to be part of the study
- •OR known case of coagulation disorders
- •OR chronic liver disease
结局指标
主要结局
changes in delay phase, baseline, acceleration, deceleration and end point phases of CWA
时间窗: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission.
Changes in the predefined Clot wave segments
Clot wave form 1st derivative changes
时间窗: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, upto 7 days post admission.
Changes in the 1 st derivative
Clot wave form 2nd derivative changes
时间窗: For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission.
Changes in the 2nd derivative
次要结局
- maximum coagulation velocity(For all aPTT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission.)
- Clotting time (CT)(For all CT samples done at admission, just prior to antivenom administration, 6 hours after antivenom administration completion and 6 hours after blood product administration, up to 7 days post admission..)
研究者
Siju V Abraham, MD
Assistant Professor in the Department of Emergency Medicine
Jubilee Mission Medical College and Research Institute