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

University of Missouri, Kansas City

Status: Withdrawn

Conditions: Anaphylaxis

Treatments: Drug: Saline; Drug: Intravenous heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT00657228

07-58

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

1

Experimental group

Description:

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.

Treatment:

Drug: Intravenous heparin