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Sponsors and Collaborators: |
Truman Medical Center Saint Luke's Hospital University of Missouri, Kansas City Emergency Physicians Foundation of KC Missouri Chapter of American College of Emergency Physicians |
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Information provided by: | Truman Medical Center |
ClinicalTrials.gov Identifier: | NCT00657228 |
To determine if intravenous unfractionated heparin (with standard therapy) for treatment of anaphylaxis results in faster time to recovery.
Condition | Intervention |
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Anaphylaxis |
Drug: Intravenous heparin Drug: Saline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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Drug: Saline
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.
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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.
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Drug: Intravenous 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. |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ryan Jacobsen, MD | 816-374-9042 | ryan.jacobsen@tmcmed.org |
Contact: Robin Barber, BSN, RN, CCRC | 816-404-5087 | robin.barber@tmcmed.org |
United States, Missouri | |
Truman Medical Center ED | |
Kansas City, Missouri, United States, 64108 | |
St. Luke's Hospital ED | |
Kansas City, Missouri, United States |
Principal Investigator: | Ryan Jacobsen, MD | Truman Medical Center |
Principal Investigator: | Stefanie Ellison, MD | Truman Medical Center |
Responsible Party: | Truman Medical Center ( Ryan Jacobsen, M.D. ) |
Study ID Numbers: | 07-58 |
Study First Received: | April 9, 2008 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00657228 |
Health Authority: | United States: Institutional Review Board |
Anaphylaxis Anaphylactoid reactions |
Calcium, Dietary Hypersensitivity Promethazine Anaphylaxis Heparin, Low-Molecular-Weight Hypersensitivity, Immediate |
Emergencies Epinephrine Heparin Diphenhydramine Calcium heparin |
Fibrin Modulating Agents Disease Attributes Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Therapeutic Uses Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |