NCT00927381已完成不适用
Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points.
研究概览
简要总结
Retrospective observational review of severe envenomation treatment with CroFab
详细描述
The objective of this study is to use previously collected retrospective observational data to compare treatment and outcome in patients treated with CroFab who have a severe envenomation to those with a mild/moderate envenomation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must involve treatment of a human patient with CroFab between January 1, 2002 and December 31, 2004
- •The record must contain all of the following:
- •Clinical signs/symptoms prior to the first dose of antivenom,
- •Documentation of all doses of antivenom used to treat the patient,
- •Indication of whether or not initial control was achieved with antivenom.
- •To be included in the Efficacy Evaluable Population (EEP) in the current analysis, each record must meet the following criteria:
- •Must contain enough information to calculate a severity score based on the 7-point severity scale.
- •All records were included in the Safety Population in the current analysis.
排除标准
- •Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
结局指标
主要结局
Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points.
时间窗: at baseline and following treatment with CroFab
次要结局
- The presence of venom effects, comparison of venom effects over time, initial control of venom effects, recurrence of venom effects, and delayed onset of venom effects.(following treatment)
研究者
研究点 (1)
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