Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 133,331
- 试验地点
- 1
- 主要终点
- Number of patients with anaphylactoid reactions of Iopromide after administration
研究概览
简要总结
Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intra-arterial administration
Patients with intra-arterial administration of Iopromide
干预措施: Iopromide (Ultravist, BAY86-4877) (Drug)
Intravenous administration
Patients with intravenous administration of Iopromide
干预措施: Iopromide (Ultravist, BAY86-4877) (Drug)
结局指标
主要结局
Number of patients with anaphylactoid reactions of Iopromide after administration
时间窗: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
次要结局
- Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide(Retrospective analysis from 31 Aug 2010 to 30 Sep 2011)
- Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide(Retrospective analysis from 31 Aug 2010 to 30 Sep 2011)