Clinical trial NCT00657228: Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic Reactions in an Emergency Department
Official title: Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anaphylaxis
Keywords: Anaphylaxis
Anaphylactoid reactions
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Truman Medical Center
name: Saint Luke's Hospital
name: Emergency Physicians Foundation of KC
name: American College of Emergency Physicians
First posted: 2008-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: Time to improve to a severity score of 1 or complete resolution of signs/symptoms.
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center ED
state: Missouri
city: Kansas City
country: United States
facility: St. Luke's Hospital ED
state: Missouri
Study officials:
affiliation: Truman Medical Center
name: Ryan Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Truman Medical Center
name: Stefanie Ellison, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampson HA, Munoz-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. doi: 10.1016/j.jaci.2005.12.1303.
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. doi: 10.1016/j.annemergmed.2006.09.033. No abstract available.
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. doi: 10.1016/j.annemergmed.2006.03.029. Epub 2006 Jun 22.
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. doi: 10.1016/S1081-1206(10)60883-6.
citation: Brown SG, Mullins RJ, Gold MS. Anaphylaxis: diagnosis and management. Med J Aust. 2006 Sep 4;185(5):283-9. doi: 10.5694/j.1326-5377.2006.tb00619.x.