[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471596":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":28,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13,18],{"label":9,"type":6,"description":10,"interventionNames":11},"IgG group","Patient in the IgG group will benefit from a blood sampling of 5 ml (for realization of a basophil activation test) and a blood sampling of 250 ml",[12],"Diagnostic Test: IgG group",{"label":14,"type":6,"description":15,"interventionNames":16},"IgE group","Patient in the IgE will benefit from a blood sampling of 5 ml (for realization of a basophil activation test) and a bone marrow sampling (approx 2 ml)",[17],"Diagnostic Test: IgE group",{"label":19,"type":6,"description":20,"interventionNames":21},"IgG group + IgE group","Patient in the IgG + IgE will benefit from a blood sampling of 5 ml (for realization of a basophil activation test), a blood sampling of 250 ml and a bone marrow sampling (approx 2 ml)",[22],"Diagnostic Test: IgG group + IgE group",[24,29,32],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","Will be performed :\n\n* a blood sampling of 5 ml (for realization of a basophil activation test)\n* a blood sampling of 250 ml",[9],null,{"type":25,"name":14,"description":30,"armGroupLabels":31,"otherNames":28},"Will be performed :\n\n* a blood sampling of 5 ml (for realization of a basophil activation test)\n* a bone marrow sampling",[14],{"type":25,"name":19,"description":33,"armGroupLabels":34,"otherNames":28},"* a blood sampling of 5 ml (for realization of a basophil activation test)\n* a blood sampling of 250 ml\n* a bone marrow sampling",[19],[36],{"name":37,"affiliation":5,"role":38},"Aurelie Gouel, MD, PhD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":28,"email":43},"CONTACT","00-33-1-40-25-83-55","aurelie.gouel@aphp.fr",{"name":45,"role":41,"phone":46,"phoneExt":28,"email":47},"Pierre Bruhns, PhD","00-33-1-45-68-86-29","bruhns@pasteur.fr",[49],{"facility":50,"status":51,"city":52,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":28},"Hôpital Bichat claude Bernard","RECRUITING","Paris","75018","France","FR",{"type":57,"coordinates":58},"Point",[59,60],2.3488,48.85341,{"lat":60,"lon":59},{"type":63,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[65],{"name":66,"class":67},"Institut Pasteur","INDUSTRY","100471596","repertoire-and-properties-of-anti-drug-antibodies-involved-in-immediate-hypersensitivity-in-the-operating-room-100471596",false,"NCT05420935","Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room","MEDIREP","Inclusion Criteria:\n\nCommon to both groups:\n\n* Age ≥ 18 years old and ≤ 70 years old\n* 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\n* Patient having benefited from an allergy-anaesthesia consultation in the investigator center\n\nFor IgE group:\n\n\\- presence of at least one positive skin test to one of the suspected agent (curare and\u002For antibiotic) during the allergist consultation\n\nFor the IgG group:\n\n\\- 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 \u002F or the consultation of allergology.\n\nExclusion Criteria:\n\nCommon to both groups:\n\n* Absence of written informed consent\n* Protected person: under guardianship or curatorship\n* Patient without social security\n* Pregnancy of breast feeding\n* Ongoing immunosuppressive or chemotherapy\n* Acute heart failure\n* Patient included in another interventional research with an exclusion period\n\nFor IgE group:\n\n* Taking oral or injectable anticoagulants\n* Taking a double antiplatelet aggregation\n* Previous sternotomy\n* Previous thoracic radiation therapy\n* Known allergy to local anesthesic or iodinated skin products\n* Previous major sternal cutaneous lesions\n\nPrerequisites for carrying out the sternal sample in order to carry out a myelogram (IgE group):\n\n* Leukocytes \\> 4 giga\u002FL in the 2 months preceding inclusion\n* Platelets \\> 100,000 \u002F mm3 in the 2 months preceding inclusion\n\nFor the IgG group\n\n* Orthostatic hypotension\n* Realization of a blood donation in the 6 to 8 weeks preceding inclusion\n\nPrerequisites for performing the blood sample (IgG group):\n\n\\- Hemoglobin \\> 12.5 g\u002FdL for women and \\> 13 g\u002FdL for men in the 2 months preceding inclusion","ALL","18 Years","70 Years",{"count":79,"type":80},40,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nBased 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.",[86,87,88,89],"Hypersensitivity, Immediate","Peri-operative Injury","Antibiotic Allergy","Antibody Hypersensitivity",[91],"Hypersensitivity, IgE, IgG, repertoire, NMBA, anaphylaxis","2024-09-02",{"date":94,"type":95},"2024-09-19","ACTUAL",{"date":97,"type":95},"2023-04-12",{"date":99,"type":80},"2033-12-15",{"name":5,"class":6},1]