Hypersensitivity Clinical Trial
Official title:
Standardised Drug Provocation Testing in Perioperative Hypersensitivity
The goal of this clinical trial is to evaluate the safety and outcome of systematic drug provocation testing with anaesthetics at therapeutic doses in adult patients undergoing diagnostic work-up for perioperative hypersensitivity.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 30, 2025 |
Est. primary completion date | October 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients consulting the allergology department of the Antwerp University hospital medical with a history consistent with perioperative hypersensitivity - Indication for diagnostic work-up as determined at an interdisciplinary meeting between allergologists and anaesthetists - willing to sign separate informed consent forms for both general anaesthesia and the Drug Provocation Test. Exclusion Criteria: - patient refusal - incomplete diagnostic work-up - history inconsistent with perioperative hypersensitivity |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypersensitivity during DPT | Prevalence of hypersensitivity during direct provocation for drugs that tested negatively in conventional tests. | 1 hour | |
Secondary | Severe reactions during DPT | Prevalence of severe (NAP 3-4) hypersensitivity reactions during direct provocation testing | 1 hour | |
Secondary | Adverse events during DPT | Prevalence of adverse events during or after direct provocation testing | 1 hour | |
Secondary | Sensitivity of conventional tests | Sensitivity of skin tests, specific IgE and basophil activation tests for anaesthetics | 1 hour |
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