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The Role of the Coagulation Pathways in Recurrent Angioedema (Angiocoag)

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ClinicalTrials.gov Identifier: NCT02892682
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.

Condition or disease Intervention/treatment Phase
Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency Other: BLOOD TEST Not Applicable

Detailed Description:
Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways. the main objective is to highlight a difference between the rates of different coagulation factors in the 3 groups presenting different categories of angiodemes patients with a group of patients with isolated superficial chronic urticaria

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of the Coagulation Pathways in Recurrent Angioedema
Actual Study Start Date : May 31, 2016
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Arm 1 AE-Bk
Arm of the recurring angiodeme medié by the bradykinine: blood test
Other: BLOOD TEST
Arm 2 AE-Mast
Superficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test
Other: BLOOD TEST
ARM 3 AEI
Arm recurring angiodemes isolate idiopathique not hostaminergique: blood test
Other: BLOOD TEST
ARM 4 US
Arm of superficial nettle rashes: blood test
Other: BLOOD TEST



Primary Outcome Measures :
  1. Levels of several coagulation pathway markers in each group [ Time Frame: 24 Months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • recurrent angioderma

Exclusion Criteria:

  • anticoagulant therapy, diseases of hemostasis

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): NCT02892682


Contacts
Contact: Aurélie Du Thanh, MD, Ph D 33(0)467336937 a-du_thanh@chu-montpellier.fr
Contact: NADIA raison-Peyron, MD +33(0)467336957 n-raison@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: Aurelie du-Thanh, MD, PhD    +33(0)467336937    a-du_thanh@chu-montpellier.fr   
Contact: Nadia Raison-Peyron, MD    +33 (0) 467336957    n-raison@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02892682     History of Changes
Other Study ID Numbers: UF 9650
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Urticaria
Angioedema
Angioedemas, Hereditary
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn