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CompletedNCT01679912SOS AOHUpdated Dec 13, 2016

A Call Center During HAE Attacks (SOS HAE)

A Phase 4 interventional study of phone to the call center in Hereditary Angioedema, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-13.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Hereditary Angioedema

Keywords

  • Hereditary angioedema
  • Emergency Medical Service
  • Health care coast
  • Telephone
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In context

Angioedema

164 studies on the registry are indexed under Angioedema; 19 are open to participants now.

This study's enrollment of 200 is above the median of 44 across 111 interventional studies indexed under Angioedema.

Browse Angioedema studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • pregnant woman
  • recent history of myocardial infarction
  • recent history of stroke
  • allergy to icatibant or C1 inhibitor concentrate
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    1: phone to call center

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

    Other: phone to the call center

  • No intervention
    2: usual strategy

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

Interventions

  • Otherphone to the call center

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

06

What researchers measure

Primary outcomes

  1. Number of hospital admissions for angioedema attack- no (%)

    Time frame: at 2 years

Secondary outcomes

  1. Number of ICU admissions - no (%)

    Time frame: at 2 years

  2. Number of ED admissions - no (%)

    Time frame: at 2 years

  3. Number of hospital admissions for others causes - no (%)

    Time frame: at 2 years

  4. Number of intubations - no (%)

    Time frame: at 2 years

  5. Number of EMS interventions - no (%)

    Time frame: at 2 years

  6. Number of working days lost

    Time frame: at 2 years

  7. Mortality - no (%)

    Time frame: at 2 years

  8. Mortality for angioedema attack- no (%)

    Time frame: at 2 years

  9. Cost of angioedema attacks

    Time frame: at 2 years

07

Study locations

1 site
  • SAMU 93 - Hôpital Avicenne
    Bobigny, Ile de France 93000, France
08

References and documents

Publications

  • 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. PubMed 31109849 ↗
  • 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. PubMed 29503044 ↗
  • 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. PubMed 27140403 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01679912
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Sep 6, 2012
Start date
Mar 2013
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Dec 13, 2016

Study contacts

Frédéric ADNET, MD,PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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