IRCT20180515039672N2已完成3 期
Phase 3, multi-center, randomized, two-arm, parallel, double blinded, active controlled for non-inferiority evaluation of efficacy and safety of snake anti-venom produced by Padra Serum Alborz in comparison with snake anti-venom produced by Razi Vaccine and Serum Research Institute in snakebite victims.
Padra Serum Alborz Company0 个研究点目标入组 98 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 years 至 60 years（—）
- 性别
- All
入选标准
- •History of snakebite
- •Informed consent for participating in the study
- •Men or Women victims with age of 2 to 60 years
- •Victims who arrive at mentioned hospitals within 12 hours after snakebite
- •Victims who need anti-venom according to the bite severity scale
- •Victims who have Iranian nationality (having national ID)
排除标准
- •Victims with history of allergy to horse serum
- •Victims who have experience of prior treatment with snake or scorpion antivenom due to snakebite or scorpion sting in the past.
- •Victims with two or more number of bites on arrival at hospital.
- •Victims who already have received antivenom prior to reach to hospital.
- •Victims who do wound manipulation (incision, suction, burning and so on) before hospital entrance.
- •Victims with life threatening bleeding (such as bleeding in mouth and upper respiratory tract)
- •Victims who receive heparin and warfarin
- •Victims with history of coagulopathy, cardiac disease, neuromuscular disease, kidney and liver failure.
- •Pregnant or breastfeeding women.
- •Victims who have sea snakebite.
- •Victims who need for mechanical ventilation at the time of registration.
研究者
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