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A Call Center During HAE Attacks (SOS HAE) (SOS AOH)

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ClinicalTrials.gov Identifier: NCT01679912
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Other: phone to the call center Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.
Study Start Date : March 2013
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
recommendations to phone to the call center for all the patients who have an acute attack
No Intervention: 2: usual strategy
usual strategy. No intervention (patients does not change their practice)



Primary Outcome Measures :
  1. Number of hospital admissions for angioedema attack- no (%) [ Time Frame: at 2 years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679912


Locations
France
SAMU 93 - Hôpital Avicenne
Bobigny, Ile de France, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frédéric ADNET, MD,PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01679912     History of Changes
Other Study ID Numbers: P110109
2012-A00044-39 ( Other Identifier: IDRCB )
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hereditary angioedema
Emergency Medical Service
Health care coast
Telephone

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn