Hereditary Angioedema Clinical Trial
— SOS AOHOfficial title:
Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.
Verified date | December 2016 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
This clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (SOS HAE) from a group of patients does not change their practice.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with an hereditary angioedema followed in a reference center for bradykinin angioedema (CRéAk) - Patient's age = 18 years - Consent to the participation in the study - Affiliated to social security Exclusion Criteria: - pregnant woman - recent history of myocardial infarction - recent history of stroke - allergy to icatibant or C1 inhibitor concentrate |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | SAMU 93 - Hôpital Avicenne | Bobigny | Ile de France |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of hospital admissions for angioedema attack- no (%) | at 2 years | Yes | |
Secondary | Number of ICU admissions - no (%) | at 2 years | Yes | |
Secondary | Number of ED admissions - no (%) | at 2 years | Yes | |
Secondary | Number of hospital admissions for others causes - no (%) | at 2 years | Yes | |
Secondary | Number of intubations - no (%) | at 2 years | Yes | |
Secondary | Number of EMS interventions - no (%) | at 2 years | Yes | |
Secondary | Number of working days lost | at 2 years | Yes | |
Secondary | Mortality - no (%) | at 2 years | Yes | |
Secondary | Mortality for angioedema attack- no (%) | at 2 years | Yes | |
Secondary | Cost of angioedema attacks | at 2 years | No |
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