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

Condition(s) targeted: Anaphylaxis

Intervention: Intravenous heparin (Drug); Saline (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Truman Medical Center

Official(s) and/or principal investigator(s):
Ryan Jacobsen, MD, Principal Investigator, Affiliation: Truman Medical Center
Stefanie Ellison, MD, Principal Investigator, Affiliation: Truman Medical Center

Overall contact:
Ryan Jacobsen, MD, Phone: 816-374-9042, Email: ryan.jacobsen@tmcmed.org

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Time to improve to a severity score of 1 or complete resolution of signs/symptoms.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Ryan Jacobsen, MD, Phone: 816-374-9042, Email: ryan.jacobsen@tmcmed.org

Truman Medical Center ED, Kansas City, Missouri 64108, United States

St. Luke's Hospital ED, Kansas City, Missouri, United States

Related 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.

Starting date: December 2009
Ending date: December 2010
Last updated: September 16, 2009