Clinical trial NCT01679912: A Call Center During HAE Attacks (SOS HAE)
Official title: Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hereditary Angioedema
Keywords: Hereditary angioedema
Emergency Medical Service
Health care coast
Telephone
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of hospital admissions for angioedema attack- no (%)
timeFrame: at 2 years
Secondary outcomes:
measure: Number of ICU admissions - no (%)
timeFrame: at 2 years
measure: Number of ED admissions - no (%)
timeFrame: at 2 years
measure: Number of hospital admissions for others causes - no (%)
timeFrame: at 2 years
measure: Number of intubations - no (%)
timeFrame: at 2 years
measure: Number of EMS interventions - no (%)
timeFrame: at 2 years
measure: Number of working days lost
timeFrame: at 2 years
measure: Mortality - no (%)
timeFrame: at 2 years
measure: Mortality for angioedema attack- no (%)
timeFrame: at 2 years
measure: Cost of angioedema attacks
timeFrame: at 2 years
Other outcomes:
Locations:
city: Bobigny
country: France
facility: SAMU 93 - Hôpital Avicenne
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frédéric ADNET, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Javaud N, Altar A, Fain O, Reuter PG, Desmaizieres M, Petrovic T, Ghazali A, Durand-Zaleski I, Bouillet L, Vicaut E, Launay D, Martin L, Floccard B, Gompel A, Sobel A, Boccon-Gibod I, Kanny G, Lapostolle F, Adnet F. Hereditary angioedema, emergency management of attacks by a call center. Eur J Intern Med. 2019 Sep;67:42-46. doi: 10.1016/j.ejim.2019.05.007. Epub 2019 May 18.
citation: Javaud N, Fain O, Durand-Zaleski I, Launay D, Bouillet L, Gompel A, Sobel A, Woimant M, Rabetrano H, Petrovic T, Lapostolle F, Boccon-Gibod I, Reuter PG, Bertrand P, Mezaour M, Coppere B, Floccard B, Kanny G, Baker E, Martin L, Vicaut E, Adnet F. Specialist Advice Support for Management of Severe Hereditary Angioedema Attacks: A Multicenter Cluster-Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):194-203.e1. doi: 10.1016/j.annemergmed.2018.01.053. Epub 2018 Mar 2.
citation: Javaud N, Fain O, Durand-Zaleski I, Launay D, Bouillet L, Gompel A, Sobel A, Woimant M, Rabetrano H, Petrovic T, Lapostolle F, Boccon-Gibod I, Reuter PG, Bertrand P, Coppere B, Floccard B, Kanny G, Martin L, Vicaut E, Adnet F. Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial. Trials. 2016 Apr 30;17(1):225. doi: 10.1186/s13063-016-1350-0.