Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT05420935
Eligibility Criteria:
Inclusion Criteria:
Common to both groups:
* Age ≥ 18 years old and ≤ 70 years old
* Patient having presented an allergic reaction in the operating room in the last 10 years, regardless of the grade of severity, the causative agent or the type of anesthesia
* Patient having benefited from an allergy-anaesthesia consultation in the investigator center
For IgE group:
\- presence of at least one positive skin test to one of the suspected agent (curare and/or antibiotic) during the allergist consultation
For the IgG group:
\- presence of circulating IgG-type antibodies directed against one of the suspected agents (curare, antibiotic, antiseptic), identified in the routine biological tests carried out at the time of the shock and / or the consultation of allergology.
Exclusion Criteria:
Common to both groups:
* Absence of written informed consent
* Protected person: under guardianship or curatorship
* Patient without social security
* Pregnancy of breast feeding
* Ongoing immunosuppressive or chemotherapy
* Acute heart failure
* Patient included in another interventional research with an exclusion period
For IgE group:
* Taking oral or injectable anticoagulants
* Taking a double antiplatelet aggregation
* Previous sternotomy
* Previous thoracic radiation therapy
* Known allergy to local anesthesic or iodinated skin products
* Previous major sternal cutaneous lesions
Prerequisites for carrying out the sternal sample in order to carry out a myelogram (IgE group):
* Leukocytes \> 4 giga/L in the 2 months preceding inclusion
* Platelets \> 100,000 / mm3 in the 2 months preceding inclusion
For the IgG group
* Orthostatic hypotension
* Realization of a blood donation in the 6 to 8 weeks preceding inclusion
Prerequisites for performing the blood sample (IgG group):
\- Hemoglobin \> 12.5 g/dL for women and \> 13 g/dL for men in the 2 months preceding inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05420935
Study Brief:
Protocol Section:
NCT05420935