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Mechanisms of Anaphylaxis (ANAMEK)

This study is currently recruiting participants.
Verified September 2017 by Haukeland University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03182491
First Posted: June 9, 2017
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Haukeland University Hospital
  Purpose
The purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. The study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. The investigators will also include a group of healthy controls.

Condition Intervention
Anaphylaxis Allergy Transfusion Reaction Febrile Transfusion Reaction Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Mechanisms of Anaphylaxis

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Clarify mechanisms for anaphylaxis and establish biomarkers for this syndrome [ Time Frame: 2 days ]
    Immunological/nonimmunological mechanism


Biospecimen Retention:   Samples With DNA
Serum samples, plasma samples, full blood-samples

Estimated Enrollment: 40
Actual Study Start Date: April 28, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Anaphylaxis Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test
Febrile transfusion reactions Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test
Mild allergic reactions Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test
Healthy controls Diagnostic Test: Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)
Analysis of biomarkers and basophil activation test

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults
Criteria

Inclusion Criteria:

According to the specific cohort:

  1. Diagnosis of anaphylaxis
  2. Mild allergic reaction
  3. Febrile transfusion reaction
  4. Healthy, no known allergic disease

Exclusion Criteria:

Suspicion or diagnosed sepsis Children

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182491


Contacts
Contact: Morten Y Isaksen, MD +4799769478 morten.yung.isaksen@helse-bergen.no
Contact: Torunn O Apelseth, MD, PhD +4794842045 torunn.oveland.apelseth@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Morten Y Isaksen, MD    +4799769478    morten.yung.isaksen@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Study Director: Torunn O Apelseth, MD, PhD Haukeland University Hospital
Principal Investigator: Morten Y Isaksen, MD Haukeland University Hospital
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03182491     History of Changes
Other Study ID Numbers: 2016/1635
First Submitted: June 7, 2017
First Posted: June 9, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Platelet activating factor
Basophil activation test
Anaphylatoxins

Additional relevant MeSH terms:
Anaphylaxis
Transfusion Reaction
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hematologic Diseases
Anaphylatoxins
Immunologic Factors
Physiological Effects of Drugs