NCT05420935Recruiting
Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 May 2022
- Start date
- 12 Apr 2023
- Primary completion date
- 12 Apr 2033
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT05420935
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 12 Apr 2023 to the primary completion date, 12 Apr 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing immunosuppressive or chemotherapy
- Previous sternotomy
- Previous thoracic radiation therapy
- Previous major sternal cutaneous lesions
- Prerequisites for carrying out the sternal sample in order to carry out a myelogram (IgE group):
Other illness
- Acute heart failure
- Known allergy to local anesthesic or iodinated skin products
Lab values
- Leukocytes \> 4 giga/L in the 2 months preceding inclusion
- Platelets \> 100,000 / mm3 in the 2 months preceding inclusion
- For the IgG group
- 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
Other
- Common to both groups:
- Absence of written informed consent
- Protected person: under guardianship or curatorship
- Patient without social security
- Pregnancy of breast feeding
- Patient included in another interventional research with an exclusion period
- For IgE group:
- Taking oral or injectable anticoagulants
- Taking a double antiplatelet aggregation
- Orthostatic hypotension
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.