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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying allergies that can happen quickly during surgeries, particularly reactions to certain drugs like muscle relaxants (curare) and antibiotics. These allergic reactions, known as acute per-anesthetic hypersensitivity reactions, can be serious and even life-threatening. The researchers aim to better understand how these allergies work and to develop ways to identify patients who might be at risk. This includes figuring out the specific antibodies involved in these reactions and creating new tools to help diagnose and treat them more effectively.

To participate in the trial, individuals need to be between 18 and 70 years old and have experienced an allergic reaction during surgery in the last 10 years. They must also have had an allergy consultation at the study center. The trial is open to all genders, and participants will undergo testing to identify the specific antibodies related to their allergic reactions. Those who join can expect to contribute to important research that could improve safety for future surgical patients by enhancing how allergies are detected and managed.

Gender

ALL

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