Hereditary Angioedema
Conditions
Keywords
Hereditary angioedema, Emergency Medical Service, Health care coast, Telephone
Brief summary
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.
Detailed description
Investigators propose a study to determine whether a call center for an acute attack of HAE associated with intervention recommendations based on systematic early treatment (self-administration at home or by a caregiver) would reduce the morbidity and the socioeconomic impact.
Interventions
OTHERphone to the call center
recommendations to phone to the call center for all the patients who have an acute attack
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hospital admissions for angioedema attack- no (%) | at 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of ED admissions - no (%) | at 2 years |
| Number of hospital admissions for others causes - no (%) | at 2 years |
| Number of intubations - no (%) | at 2 years |
| Number of EMS interventions - no (%) | at 2 years |
| Number of ICU admissions - no (%) | at 2 years |
| Mortality - no (%) | at 2 years |
| Mortality for angioedema attack- no (%) | at 2 years |
| Cost of angioedema attacks | at 2 years |
| Number of working days lost | at 2 years |
Countries
France
Outcome results
None listed