Understanding anti-drug antibodies causing hypersensitivity during anesthesia
Official title: Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room
Run by Assistance Publique - Hôpitaux de Paris · NCT05420935 · Data updated 2026-11-12
This study is trying to find out if certain antibodies in patients can help identify those at risk for severe allergic reactions to anesthesia drugs during surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Paris, Paris) |
| Status | Recruiting |
| Started | April 12, 2023 |
| Main results expected | April 12, 2033 |
| Study ends | December 15, 2033 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT05420935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 70 who have experienced an allergic reaction in the operating room within the last 10 years.
✕Probably not a fit
Patients who have not experienced any allergic reactions during anesthesia or are outside the age range will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates acute hypersensitivity reactions that occur during anesthesia, particularly focusing on the role of anti-drug antibodies in these reactions. It aims to identify patients at risk of severe allergic responses to NeuroMuscular Blocking Agents (NMBA) and antibiotics used in surgical procedures. The study will categorize participants into groups based on the presence of IgE or IgG antibodies related to these agents, utilizing skin tests and routine biological tests for diagnosis. By improving the detection of at-risk patients, the study seeks to enhance patient safety during surgeries.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of patients at risk for severe allergic reactions during anesthesia, potentially reducing mortality rates.
How similar studies have gone: While the approach of identifying anti-drug antibodies is established, the specific focus on NMBA-related hypersensitivity reactions is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hôpital Bichat claude Bernard
Paris, Paris, France Recruiting
Study contacts
- Principal investigator: Aurelie Gouel, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Aurelie Gouel, MD, PhD
- Email: aurelie.gouel@aphp.fr
- Phone: 00-33-1-40-25-83-55
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.