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Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room

RecruitingNAAges 18 Years - 70 YearsAllAssistance Publique - Hôpitaux de Paris
NCT05420935 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 responsible for these reactions in France are curare in 60% of cases, followed by antibiotics. The main mechanism mentioned is an immediate systemic hypersensitivity immune reaction mediated by IgE antibodies (anaphylaxis). NeuroMuscular Blocking Agents (NMBA; curare) relax skeletal muscles to facilitate surgeries and permit intubation, but lead to adverse reactions: (a) severe hypersensitivity reactions (anaphylaxis) thought to rely on pre-existing anti-NMBA antibodies; (b) complications due to postoperative residual curarization. Identification of patients at risk remains suboptimal due to the lack of adequate tools to detect anti-NMBA antibodies. A capturing agent exists for only one out of the fou

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📋 Eligibility rules (as published)
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
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What it tests

  • IgG group
  • IgE group
  • IgG group + IgE group
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Where

1 site
Hôpital Bichat claude Bernard
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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