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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00657228
Enrollment
0
Registered
2008-04-14
Start date
2009-12-31
Completion date
2010-12-31
Last updated
2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaphylaxis

Keywords

Anaphylaxis, Anaphylactoid reactions

Brief summary

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

Detailed 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.

Interventions

DRUGIntravenous heparin

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.

DRUGSaline

Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.

Sponsors

Truman Medical Center
CollaboratorOTHER
Saint Luke's Hospital
CollaboratorUNKNOWN
Emergency Physicians Foundation of KC
CollaboratorUNKNOWN
American College of Emergency Physicians
CollaboratorOTHER
University of Missouri, Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Time to improve to a severity score of 1 or complete resolution of signs/symptoms.6 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026