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

Primary Purpose

Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BLOOD TEST
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recurrent angioderma

Exclusion Criteria:

  • anticoagulant therapy, diseases of hemostasis

Sites / Locations

  • Montpellier University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Arm 1 AE-Bk

Arm 2 AE-Mast

ARM 3 AEI

ARM 4 US

Arm Description

Arm of the recurring angiodeme medié by the bradykinine: blood test

Superficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test

Arm recurring angiodemes isolate idiopathique not hostaminergique: blood test

Arm of superficial nettle rashes: blood test

Outcomes

Primary Outcome Measures

Levels of several coagulation pathway markers in each group

Secondary Outcome Measures

Full Information

First Posted
September 2, 2016
Last Updated
August 24, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02892682
Brief Title
The Role of the Coagulation Pathways in Recurrent Angioedema
Acronym
Angiocoag
Official Title
The Role of the Coagulation Pathways in Recurrent Angioedema
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 AE-Bk
Arm Type
Other
Arm Description
Arm of the recurring angiodeme medié by the bradykinine: blood test
Arm Title
Arm 2 AE-Mast
Arm Type
Other
Arm Description
Superficial nettle rash group recurring angiodemes associated with superficial nettle rash: blood test
Arm Title
ARM 3 AEI
Arm Type
Other
Arm Description
Arm recurring angiodemes isolate idiopathique not hostaminergique: blood test
Arm Title
ARM 4 US
Arm Type
Other
Arm Description
Arm of superficial nettle rashes: blood test
Intervention Type
Other
Intervention Name(s)
BLOOD TEST
Primary Outcome Measure Information:
Title
Levels of several coagulation pathway markers in each group
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recurrent angioderma Exclusion Criteria: anticoagulant therapy, diseases of hemostasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie Du Thanh, MD, Ph D
Phone
33(0)467336937
Email
a-du_thanh@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
NADIA raison-Peyron, MD
Phone
+33(0)467336957
Email
n-raison@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelie du-Thanh, MD, PhD
Phone
+33(0)467336937
Email
a-du_thanh@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Nadia Raison-Peyron, MD
Phone
+33 (0) 467336957
Email
n-raison@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Role of the Coagulation Pathways in Recurrent Angioedema

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