NCT01679912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

3.5 years

First QC Date

August 21, 2012

Last Update Submit

December 12, 2016

Conditions

Hereditary Angioedema

Keywords

Hereditary angioedemaEmergency Medical ServiceHealth care coastTelephone

Outcome Measures

Primary Outcomes (1)

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

    at 2 years

Secondary Outcomes (9)

  • Number of ICU admissions - no (%)

    at 2 years

  • Number of ED admissions - no (%)

    at 2 years

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

    at 2 years

  • Number of intubations - no (%)

    at 2 years

  • Number of EMS interventions - no (%)

    at 2 years

  • +4 more secondary outcomes

Study Arms (2)

1: phone to call center

EXPERIMENTAL

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

Other: phone to the call center

2: usual strategy

NO INTERVENTION

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

Interventions

phone to the call centerOTHER

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

1: phone to call center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAMU 93 - Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (3)

  • 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.

    PMID: 31109849DERIVED

  • 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.

    PMID: 29503044DERIVED

  • 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.

    PMID: 27140403DERIVED

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

AngioedemaVascular DiseasesCardiovascular DiseasesHereditary Complement Deficiency DiseasesPrimary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesImmunologic Deficiency Syndromes

Study Officials

  • Frédéric ADNET, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

September 6, 2012

Study Start

March 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

FR(1)