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

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

Detailed Description
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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.

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

Conditions
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Anaphylaxis

Intervention / Treatment
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* Drug: Intravenous heparin
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) plus an equal volume bolus of normal saline after the first doses are administered. | Drug: Saline<br>* Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.<br>|
| Experimental: 1<br>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. | Drug: Intravenous heparin<br>* Intravenous heparin as an adjunct for the treatment of anaphylactic/anaphylactoid reactions in the Emergency Department. To determine if a single bolus of intravenous unfractionated heparin (in conjunction with standard therapy) given to patients with anaphylactic/anaphylactoid reactions results in a faster time to recovery when compared to standard therapy alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to improve to a severity score of 1 or complete resolution of signs/symptoms. |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaphylaxis, Anaphylactoid reactions