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A Call Center During HAE Attacks (SOS HAE)

NCT ID: NCT01679912

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Hereditary Angioedema

Keywords

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Hereditary angioedema Emergency Medical Service Health care coast Telephone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: phone to call center

recommendations to phone to the call center for all the patients who have an acute attack

Group Type EXPERIMENTAL

phone to the call center

Intervention Type OTHER

recommendations to phone to the call center for all the patients who have an acute attack

2: usual strategy

usual strategy. No intervention (patients does not change their practice)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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phone to the call center

recommendations to phone to the call center for all the patients who have an acute attack

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric ADNET, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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SAMU 93 - Hôpital Avicenne

Bobigny, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31109849 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29503044 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27140403 (View on PubMed)

Other Identifiers

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2012-A00044-39

Identifier Type: OTHER

Identifier Source: secondary_id

P110109

Identifier Type: -

Identifier Source: org_study_id