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

Anaphylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00657228
• Other study ID #: 07-58
• Status: Withdrawn
• Phase: N/A
• First received: April 9, 2008
• Last updated: January 5, 2017
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2017
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaphylaxis
• Emergencies

Intervention

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

Locations

Country	Name	City	State
United States	St. Luke's Hospital ED	Kansas City	Missouri
United States	Truman Medical Center ED	Kansas City	Missouri

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

References & Publications (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 article text. — View Citation

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. — View Citation

Greenberg MR. Response to: Heparin reverses anaphylactoid shock in a porcine model. Ann Emerg Med. 2007 Apr;49(4):541-2; author reply 542. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to improve to a severity score of 1 or complete resolution of signs/symptoms.		6 hours	Yes