A Call Center During HAE Attacks (SOS HAE)

Phase 4

Completed

• Conditions: Hereditary Angioedema
• Interventions: Other: phone to the call center

• 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.

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Study Start: 2013-03
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-13

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

Arm && Interventions

Group	Intervention	Description
1: phone to call center	phone to the call center	recommendations to phone to the call center for all the patients who have an acute attack

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 hospital admissions for others causes - no (%)	at 2 years
Number of working days lost	at 2 years
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

Trial Locations

Locations (1)

SAMU 93 - Hôpital Avicenne; 🇫🇷 Bobigny, Ile de France, France