Status:
RECRUITING
Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut Pasteur
Conditions:
Hypersensitivity, Immediate
Peri-operative Injury
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsibl...
Detailed Description
Acute per-anesthetic hypersensitivity reaction (HSA-PA) is a rapidly occurring systemic reaction following injection of a drug during anesthesia (mortality between 3 and 9%). The substances responsibl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2033
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05420935
Start Date
April 12 2023
End Date
December 15 2033
Last Update
September 19 2024
Active Locations (1)
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1
Hôpital Bichat claude Bernard
Paris, Paris, France, 75018