Actively Recruiting
Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-09-19
40
Participants Needed
1
Research Sites
557 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
I
Institut Pasteur
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 four most used NMBAs, allowing reversal of profound curarization. Case reports suggested that it might also ameliorate an ongoing anaphylaxis due to that NMBA. Based on strong preliminary results, our study proposes to characterize anti-drugs antibody repertoires in patients with various NMBA or antibiotics-anaphylaxis, describe activation pathways leading to anaphylaxis, develop and validate diagnostic and therapeutic molecules to ameliorate patient screening, NMBA-anaphylaxis and reverse profound neuromuscular block.
CONDITIONS
Official Title
Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old
- Patient experienced an allergic reaction during surgery within the last 10 years
- Patient had an allergy anesthesia consultation at the investigator center
- For IgE group: positive skin test to suspected agent (curare and/or antibiotic)
- For IgG group: presence of circulating IgG antibodies against suspected agents (curare, antibiotic, antiseptic) identified in routine tests
You will not qualify if you...
- No written informed consent
- Under guardianship or curatorship
- No social security
- Pregnant or breastfeeding
- Ongoing immunosuppressive treatment or chemotherapy
- Acute heart failure
- Currently in another interventional research study with exclusion period
- For IgE group: taking oral or injectable anticoagulants
- For IgE group: taking double antiplatelet therapy
- For IgE group: previous sternotomy
- For IgE group: previous thoracic radiation therapy
- For IgE group: known allergy to local anesthetics or iodinated skin products
- For IgE group: previous major sternal skin lesions
- For IgE group: leukocytes must be >4 giga/L within 2 months before inclusion
- For IgE group: platelets must be >100,000/mm3 within 2 months before inclusion
- For IgG group: orthostatic hypotension
- For IgG group: blood donation in the 6 to 8 weeks before inclusion
- For IgG group: hemoglobin >12.5 g/dL (women) or >13 g/dL (men) within 2 months before inclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Bichat claude Bernard
Paris, Paris, France, 75018
Actively Recruiting
Research Team
A
Aurelie Gouel, MD, PhD
CONTACT
P
Pierre Bruhns, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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