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

NCT00657228 | Withdrawn DMC

• 1 other identifier: 07-58
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Anaphylaxis

Keywords

Anaphylaxis; Anaphylactoid reactions

Outcome Measures

Primary Outcomes (1)

• Time to improve to a severity score of 1 or complete resolution of signs/symptoms.

  6 hours

Study Arms (2)

2

PLACEBO COMPARATOR

Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) plus an equal volume bolus of normal saline after the first doses are administered.

Drug: Saline

1

EXPERIMENTAL

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

Interventions

Intravenous heparin DRUG

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.

1

Saline DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• Truman Medical Center: collaborator
• Saint Luke's Hospital: collaborator
• Emergency Physicians Foundation of KC: collaborator
• American College of Emergency Physicians: collaborator

Study Sites (2)

Truman Medical Center ED

Kansas City, Missouri, 64108, United States

Location

St. Luke's Hospital ED

Kansas City, Missouri, United States

Location

Related Publications (5)

• 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.

  PMID: 16461139 BACKGROUND

• 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.

  PMID: 17371711 BACKGROUND

• 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.

  PMID: 16857468 BACKGROUND

• 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.

  PMID: 17458433 BACKGROUND

• 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.

  PMID: 16948628 BACKGROUND

MeSH Terms

Conditions

Anaphylaxis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ryan Jacobsen, MD

  Truman Medical Center

  PRINCIPAL INVESTIGATOR

• Stefanie Ellison, MD

  Truman Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (2)