A Call Center During HAE Attacks (SOS HAE)
Phase 4
Completed
- Conditions
- Hereditary Angioedema
- Registration Number
- NCT01679912
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of hospital admissions for angioedema attack- no (%) at 2 years
- Secondary Outcome Measures
Name Time Method Number of ICU admissions - no (%) at 2 years Number of intubations - no (%) at 2 years Mortality - no (%) at 2 years Number of ED admissions - no (%) at 2 years Number of EMS interventions - no (%) at 2 years Mortality for angioedema attack- no (%) at 2 years Cost of angioedema attacks at 2 years Number of hospital admissions for others causes - no (%) at 2 years Number of working days lost at 2 years
Trial Locations
- Locations (1)
SAMU 93 - Hôpital Avicenne
🇫🇷Bobigny, Ile de France, France
SAMU 93 - Hôpital Avicenne🇫🇷Bobigny, Ile de France, France