Angiocoag: The Role of the Coagulation Pathways in Recurrent Angioedema

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02892682
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 90
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Spotaneous Urticaria, Idiopathic Non Histaminergic Angioderma, Hereditary Angioedema With C1 Inhibitor Deficiency	Other: BLOOD TEST	N/A

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 Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Levels of several coagulation pathway markers in each group [24 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• recurrent angioderma

Exclusion Criteria:

• anticoagulant therapy, diseases of hemostasis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montpellier University Hospital	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02892682
• Other Study ID Numbers: UF 9650
• First Posted: Sep 8, 2016
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Angioedema; Angioedemas, Hereditary; Urticaria

Study Results

No Results Posted as of Aug 25, 2022