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临床试验/NCT01619605
NCT01619605已完成不适用

The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis

Mahidol University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Change of Serum tryptases

研究概览

简要总结

The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.

详细描述

The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.

Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.

Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.

In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • a history of shrimp allergy

排除标准

  • severe anaphylactic reaction from seafood
  • pregnancy
  • underlying diseases such as cardiovascular, hepatobiliary, and renal diseases
  • on systemic corticosteroid or β-blocking agents

结局指标

主要结局

Change of Serum tryptases

时间窗: baseline and 60 minutes after the onset of symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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