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

Primary Purpose

Anaphylaxis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravenous heparin
Saline
Sponsored by
University of Missouri, Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaphylaxis focused on measuring Anaphylaxis, Anaphylactoid reactions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Truman Medical Center ED
  • St. Luke's Hospital ED

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 9, 2008
Last Updated
January 5, 2017
Sponsor
University of Missouri, Kansas City
Collaborators
Truman Medical Center, Saint Luke's Hospital, Emergency Physicians Foundation of KC, American College of Emergency Physicians
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1. Study Identification

Unique Protocol Identification Number
NCT00657228
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not start.
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaphylaxis
Keywords
Anaphylaxis, Anaphylactoid reactions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) plus an equal volume bolus of normal saline after the first doses are administered.
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous heparin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.
Primary Outcome Measure Information:
Title
Time to improve to a severity score of 1 or complete resolution of signs/symptoms.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Jacobsen, MD
Organizational Affiliation
Truman Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefanie Ellison, MD
Organizational Affiliation
Truman Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Truman Medical Center ED
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St. Luke's Hospital ED
City
Kansas City
State/Province
Missouri
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16461139
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.
Results Reference
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PubMed Identifier
17371711
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.
Results Reference
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PubMed Identifier
16857468
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.
Results Reference
background
PubMed Identifier
17458433
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.
Results Reference
background
PubMed Identifier
16948628
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. Erratum In: Med J Aust. 2006 Oct 2;185(7):400. Dosage error in article text.
Results Reference
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Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic Reactions in an Emergency Department

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