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

This study has been withdrawn prior to enrollment.
(Study did not start.)
Sponsor:
Collaborators:
Saint Luke's Hospital
University of Missouri, Kansas City
Emergency Physicians Foundation of KC
American College of Emergency Physicians
Information provided by:
Truman Medical Center
ClinicalTrials.gov Identifier:
NCT00657228
First received: April 9, 2008
Last updated: March 29, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention
Anaphylaxis
Drug: Intravenous heparin
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Truman Medical Center:

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

Estimated Enrollment: 60
Study Start Date: December 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657228

Locations
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
Truman Medical Center
Saint Luke's Hospital
University of Missouri, Kansas City
Emergency Physicians Foundation of KC
American College of Emergency Physicians
Investigators
Principal Investigator: Ryan Jacobsen, MD Truman Medical Center
Principal Investigator: Stefanie Ellison, MD Truman Medical Center
  More Information

Publications:
Responsible Party: Ryan Jacobsen, M.D., Truman Medical Center
ClinicalTrials.gov Identifier: NCT00657228     History of Changes
Other Study ID Numbers: 07-58
Study First Received: April 9, 2008
Last Updated: March 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Truman Medical Center:
Anaphylaxis
Anaphylactoid reactions

Additional relevant MeSH terms:
Anaphylaxis
Emergencies
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014