Informations générales (source: ClinicalTrials.gov)
Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study (ALPHO)
Interventional
N/A
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
juillet 2014
juillet 2020
29 juin 2024
The main objective of this study is to compare pholcodine exposure in patients having
presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine
exposure in matched anaesthetised patients with injection of NMBA, who did not present
with an anaphylactic reaction (controls).
The secondary objectives of the study are:
- To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between
the case and control groups.
- To study the concordance between exposure to pholcodine in cases and controls, by
means of a patient self-questionnaire on the one hand and, on the other hand, by a
computerized drug history, supplemented where relevant by the drug master file.
- To study the impact of taking 1, 2 or 3 sources in account for pholcodine
exposition.
- To study the association between exposure to pholcodine and the presence/levels of
pholcodine-specific IgE, reflecting sensitisation to pholcodine.
- To study NMBA and pholcodine cross-sensitisation by testing skin reactions to
pholcodine in case patients allergic to (at least) one NMBA.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Dan LONGROIS, MD- PHD | Contact (sur clinicalTrials) | |||
| IFSI AP-HP DE L'HÔPITAL TENON | ANGELE SORIA, Dr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Nancy - 54000 - Nancy - France | Gérard AUDIBERT, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU d' ANGERS - Angers - France | Martine DROUET, Dr | Contact (sur clinicalTrials) | |||
| CHU de Besançon - 25030 - Besançon - France | Pascal GIRARDIN, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14000 - Caen - France | Delphine MARIOTTEFAUSSART, MD | Contact (sur clinicalTrials) | |||
| CHU de Clermont-Ferrand - 63003 - Clermont- Ferrand - France | Omar OUTTAS, MD | Contact (sur clinicalTrials) | |||
| CHU de MONTPELLIER - 34000 - Montpellier - France | Pascal DEMOLY, Pr | Contact (sur clinicalTrials) | |||
| CHU de NANTES - Nantes - France | ANAIS PIPET, Dr | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86000 - Poitiers - France | Marion VERDAGUER, MD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - 76000 - Rouen - France | Yannick MEUNIER, MD | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - 670000 - Strasbourg - France | Fréderic DE BLAY, MD- PHD | Contact (sur clinicalTrials) | |||
| CHU de TOURS - Tours - France | Cyrille HOARAU, Dr | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - 69495 - Pierre-Bénite - France | Vincent PIRIOU, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - 13915 - Marseille - France | Marion GOUITAA-DETTORI, MD | Contact (sur clinicalTrials) | |||
| CHRU de Lille - 59037 - Lille - France | FACON Alain, MD | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - 33000 - Bordeaux - France | Maryline Bordes | Contact (sur clinicalTrials) | |||
| CHU de Dijon - 21033 - Dijon - France | Sandrine SELTZER, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87042 - Limoges - France | Isabelle ORSEL, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - 06000 - Nice - France | Sylvie LEROY, MD | Contact (sur clinicalTrials) | |||
| CHU de Reims - 51100 - Reims - France | Jean-Marc MALINVOSKY, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU de Saint Etienne - 42055 - Saint- Etienne - France | Charles DZVIGA, MD | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - 31059 - Toulouse - France | Alain DIDIER, MD-PHD | Contact (sur clinicalTrials) | |||
| Fondation Hôpital St Joseph - 75007 - Paris - France | Marie-Laure MEGRET-GABEAUD, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Male or female, age ≥ 2 years old.
- Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of
occurrence of peranaesthetic anaphylactic reaction during anaesthesia with
administration of NMBAs (only for case patient).
- Having given his/her consent (or the 2 parents consent for minors).
- Affiliated with a social security scheme or dependent.
- Able to answer a medicinal product intake questionnaire
- In a clinical condition compatible with skin tests (no skin disease or psychiatric
illness, etc.) (only for case patient)
- Having stopped any anti-histamine treatment at least 8 days previously (only for
case patient).
- With positive skin test for the suspected NMBA (ony for case patient).
- Patient anaesthetised in a control recruitment centre (only for control patients)
- Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic
anaphylactic reaction whatever his medical history (only for control patients)
- Male or female, age ≥ 2 years old.
- Referred to anaesthesia-allergy consultation within (approximately) 6 to 12 weeks of
occurrence of peranaesthetic anaphylactic reaction during anaesthesia with
administration of NMBAs (only for case patient).
- Having given his/her consent (or the 2 parents consent for minors).
- Affiliated with a social security scheme or dependent.
- Able to answer a medicinal product intake questionnaire
- In a clinical condition compatible with skin tests (no skin disease or psychiatric
illness, etc.) (only for case patient)
- Having stopped any anti-histamine treatment at least 8 days previously (only for
case patient).
- With positive skin test for the suspected NMBA (ony for case patient).
- Patient anaesthetised in a control recruitment centre (only for control patients)
- Having undergone anaesthesia with NMBA injection, without onset of peranaesthetic
anaphylactic reaction whatever his medical history (only for control patients)
- Patients who have refused, or are unable to give their consent
- Patients who have had negative control skin tests
- Anaphylaxis suspected to be related to other drugs given on induction of
anaesthesia, eg. antibiotics
- Having presented with anaphylactic reaction during a previous anaesthesia without
NMBA injection
- Pregnant females at inclusion or during 12 months before anaesthesia