Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00657228
Other study ID # 07-58
Secondary ID
Status Withdrawn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Status Withdrawn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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04475003 - Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Recruiting NCT06065137 - Standardised Drug Provocation Testing in Perioperative Hypersensitivity N/A
Completed NCT00047918 - Blood Factors in Mastocytosis and Unexplained Anaphylaxis and Flushing N/A
Active, not recruiting NCT03953482 - Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis
Recruiting NCT05112367 - Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier
Completed NCT03366298 - Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers Phase 4
Completed NCT02958605 - Smartphone Apps for Pediatric Resuscitation N/A
Completed NCT04696822 - Bioavailability of Nasal Epinephrine Phase 1
Completed NCT03942692 - What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
Completed NCT02854969 - Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device N/A
Completed NCT03282929 - Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD) Phase 1
Recruiting NCT01326741 - Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis N/A
Recruiting NCT06445374 - Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges Phase 1
Completed NCT01217138 - Make up for the Epinephrine Autoinjector Phase 4
Completed NCT02424136 - PEAnut Anaphylaxis Predictors N/A
Completed NCT01432522 - A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine N/A
Completed NCT02028065 - A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101) Phase 1
Active, not recruiting NCT01247415 - Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine N/A
Completed NCT00868842 - Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis N/A