Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic Reactions in an Emergency Department - Full Text View

Sponsor:	Truman Medical Center
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

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:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

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:

Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, Brown SG, Camargo CA Jr, Cydulka R, Galli SJ, Gidudu J, Gruchalla RS, Harlor AD Jr, Hepner DL, Lewis LM, Lieberman PL, Metcalfe DD, O'Connor R, Muraro A, Rudman A, Schmitt C, Scherrer D, Simons FE, Thomas S, Wood JP, Decker WW. Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006 Feb;117(2):391-7.

Greenberg MR. Response to: Heparin reverses anaphylactoid shock in a porcine model. Ann Emerg Med. 2007 Apr;49(4):541-2; author reply 542. No abstract available.

Heflin CR, Brewer KL, Hack JB, Meggs WJ. Heparin reverses anaphylactoid shock in a porcine model. Ann Emerg Med. 2006 Aug;48(2):190-3. Epub 2006 Jun 22.

Gaeta TJ, Clark S, Pelletier AJ, Camargo CA. National study of US emergency department visits for acute allergic reactions, 1993 to 2004. Ann Allergy Asthma Immunol. 2007 Apr;98(4):360-5.

Brown SG, Mullins RJ, Gold MS. Anaphylaxis: diagnosis and management. Med J Aust. 2006 Sep 4;185(5):283-9. Review. Erratum in: Med J Aust. 2006 Oct 2;185(7):400. dosage error in text.

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 February 09, 2012