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

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ClinicalTrials.gov Identifier: NCT00657228
Recruitment Status : Withdrawn (Study did not start.)
First Posted : April 14, 2008
Last Update Posted : January 9, 2017
Truman Medical Center
Saint Luke's Hospital
Emergency Physicians Foundation of KC
American College of Emergency Physicians
Information provided by:
University of Missouri, Kansas City

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

Condition or disease Intervention/treatment
Anaphylaxis Drug: Intravenous heparin Drug: Saline

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department
Study Start Date : December 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 2
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) plus an equal volume bolus of normal saline after the first doses are administered.
Drug: Saline
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.
Experimental: 1
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

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.

Primary Outcome Measures :
  1. Time to improve to a severity score of 1 or complete resolution of signs/symptoms. [ Time Frame: 6 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657228

United States, Missouri
Truman Medical Center ED
Kansas City, Missouri, United States, 64108
St. Luke's Hospital ED
Kansas City, Missouri, United States
Sponsors and Collaborators
University of Missouri, Kansas City
Truman Medical Center
Saint Luke's Hospital
Emergency Physicians Foundation of KC
American College of Emergency Physicians
Principal Investigator: Ryan Jacobsen, MD Truman Medical Center
Principal Investigator: Stefanie Ellison, MD Truman Medical Center

Responsible Party: Ryan Jacobsen, M.D., Truman Medical Center
ClinicalTrials.gov Identifier: NCT00657228     History of Changes
Other Study ID Numbers: 07-58
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by University of Missouri, Kansas City:
Anaphylactoid reactions

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Hypersensitivity, Immediate
Immune System Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Anti-Allergic Agents