跳至主要内容
临床试验/CTRI/2025/07/089960
CTRI/2025/07/089960招募中不适用

Assessing for Utility of Phospholipase A2 ELISA in Snakebite victims

FMCI1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Utility of PLA2 in snake bite patients

研究概览

简要总结

Background - Snakebite is a significant public health problem in India and recently also declared as a notifiable disease. Early identification of systemic envenomation is crutial for timely ASV administration. 20 minute whole blood clotting time is the commonly used bedside test to detect envenomation. However it lack sensitivity and specificity. Phospholipase A2 is a major enzymatic component of elapid and viper species. Hence it has emerged as a biomarker for detecting envenomation using ELISA based assays.

Objective - To evaluate the diagnostic utility of serum PLA2 measured by ELISA for detecting venomous and non venomous snakes.

Methodology - Hospital based cases control study done in the emergency medicine department of Father Muller Medical College. 100 cases of venomous bites and 100 cases on non venomous bites patients blood will be tested for levels of serum PLA2 using ELISA kits. Diagnostic performance will be assessed using sensitivity, specificity and area under curve. Relevant clinical and Laboratory parameters will be noted down.

Expected outcome - This study aims to determine whether serum PLA2 can serve as a biomarker for detecting venomous snake, support in the daignostic tool in resource limited settings.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients coming with history of snake bite.

排除标准

  • History of chronic inflammatory diseases or autoimmune conditions, use of anti-venom before hospital admission, patients on medications that may influence PLA2 levels (e.g., steroids, NSAIDs and amiodarone) Patients who have received Anti snake venom from outside hospital.

结局指标

主要结局

Utility of PLA2 in snake bite patients

时间窗: On arrival - 0 hour and 3 hours after anti snake venom

次要结局

  • Correlation of snakebite severity score & morbidity(On admission - 0 hours & at time of discharge)

研究者

发起方
FMCI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shailaja S

Father Muller Medical College

研究点 (1)

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