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临床试验/NCT00657228
NCT00657228撤回不适用

Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department

University of Missouri, Kansas City2 个研究点 分布在 1 个国家开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Time to improve to a severity score of 1 or complete resolution of signs/symptoms.

研究概览

简要总结

To determine if intravenous unfractionated heparin (with standard therapy) for treatment of anaphylaxis results in faster time to recovery.

详细描述

Anaphylaxis is a potentially life-threatening entity that requires both immediate recognition and aggressive treatment. Although anaphylaxis is infrequent, comprising only 1% of approximately 1.03 million visits to the ED each year that are related to allergic reactions, it is none the less a generally under-recognized and under-treated disease, that is worthy of study due to the potential for a fatal outcome. Recently, there has been renewed interest in a commonly used and inexpensive drug (heparin) as a novel component of therapy for anaphylactic/anaphylactoid reactions. Heflin eft al. induced anaphylactoid reactions in pigs and compared intravenous unfractionated heparin in one treatment arm to standard therapy (intravenous epinephrine and diphenhydramine) versus placebo. The study revealed that heparin rapidly reversed the shock similar to that of standard emergency treatment. Of course this single study done in pigs will not change practice, but it does warrant further investigation into the role that heparin plays in anaphylaxis in humans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • 18 years and older
  • English speaking
  • Meets one of the above definitions of anaphylaxis
  • Signs/symptoms onset <12 hours will get epinephrine or will not get epinephrine because of contraindication to epinephrine administration.

排除标准

  • History of Intracranial Hemorrhage at anytime
  • Known Cerebral Vascular Lesion (i.e. Aneurysm, Arteriovenous malformation)
  • Ischemic CVA within the last 3 months
  • Suspected Aortic Dissection
  • Active Bleeding
  • Known Bleeding/Clotting Disorder
  • Closed Head Trauma within the past 3 months
  • Major Surgery (Abdominal/Thoracic) within the last 3 weeks
  • Active GI Bleeding
  • Currently taking Warfarin
  • Allergy to Heparins
  • History of Heparin-induced Thrombocytopenia (AHA contraindications to fibrinolytic therapy 2005, Micromedix 2007)

研究组 & 干预措施

2

Placebo Comparator

Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) plus an equal volume bolus of normal saline after the first doses are administered.

干预措施: Saline (Drug)

1

Experimental

Standard therapy plus a one-time bolus of heparin at 80 U/kg (maximum dose of 10,000 Units) given immediately after the first doses of standard treatment.

干预措施: Intravenous heparin (Drug)

结局指标

主要结局

Time to improve to a severity score of 1 or complete resolution of signs/symptoms.

时间窗: 6 hours

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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