An observational study in Angio Edema Hereditary, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by University Hospital, Grenoble · Observational
Hereditary angioedema (HAE) is a rare genetic disease, it can occur at any age and evolves in flare-ups. These are subcutaneous or submucosal edemas responsible for tightness and pain. All areas can be reached. In addition, all their life, patients have an unpredictable risk of death from asphyxiating angioedema (25% mortality in the absence of specific treatment).
Surgical procedures, endoscopies and dental procedures can trigger laryngeal AE. Thus, the national reference center for angioedema (CREAK) and the latest international consensus1 recommend that all these procedures be preceded by short-term prophylaxis. The reference treatment is the C1 inhibitor 2 concentrate. But to date, there is no prospective study that has demonstrated the effectiveness of this short-term prophylaxis before dental treatment. Only a retrospective study has shown that its implementation made it possible to reduce the risk of crisis by 42% after tooth extraction 3 and that the risk of crisis was greatest within 8 hours following tooth extraction.
The C1 inhibitor concentrate must be administered IVL by a nurse within 6 hours before the procedure and therefore implies, in addition to its high cost (1500 €), an organizational burden for the patient who must plan for the passage of an IDE, the availability of the product and this sometimes for a simple dental treatment.
These constraints have two consequences for dental care: patients avoid going to the dentist to the detriment of their dental health or do not take prophylaxis with the risk of a fatal attack.
164 studies on the registry are indexed under Angioedema; 19 are open to participants now.
This study's planned enrollment of 800 is above the median of 163 across 44 observational studies indexed under Angioedema.
Browse Angioedema studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with HAE with or without C1 Inhibitor deficiency
Exclusion Criteria:
questionnaire for patient with dental procedure
the attitude of HAE patients towards dental care
Proportion of patients canceling or delaying dental care due to apprehension of a crisis or difficulties in scheduling short-term prophylaxis
Time frame: 30 minutes
Description of crises after dental care
Proportion of patients with an attack within 48 hours after treatment, severity and location, Short-term prophylaxis used, Long-term prophylaxis used, Types of angioedema
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble