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Completed

NCT Number: NCT01679912

A Call Center During HAE Attacks (SOS HAE)

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.

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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SAMU 93 - Hôpital Avicenne

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phone to the call center

Other

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

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.

Acronym: SOS AOH

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 6, 2012
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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