跳至主要内容
临床试验/NCT03525496
NCT03525496已完成不适用

Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents

Centre Hospitalier Régional Metz-Thionville1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2018年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Percentage of immediate hypersensitivity reactions

研究概览

简要总结

Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable effects, the reintroduction tests are not conducted along similar lines to throughout scan or arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of injected volume and doses progression. It should be evaluated the relevance of the reintroduction tests with injection of a low volume and ensure the absence of reaction during the ICA injections Under real conditions.

The investigators are assuming that the realization of a provocation test by intravenous reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison with only cutaneous tests.

详细描述

The main objective of this study will be to estimate the negative predictive value of the combination of cutaneous tests and provocation test by intravenous reintroduction in the IHS to iodinated contrast agents.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Major patient
  • Having suffered single-blind reintroduction
  • Having benefited from cutaneous tests and ICA reintroduction test in the framework of IHS

排除标准

  • Patient with delayed hypersensitivity
  • Opposed to use data

结局指标

主要结局

Percentage of immediate hypersensitivity reactions

时间窗: Day 1

Occurrence of immediate hypersensitivity reactions after an injection of ICA

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (1)

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