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New treatment option for Hypersensitivity, Immediate
Official title Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room
ClinicalTrials.gov ID: NCT05420935
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Patient having benefited from an allergy-anaesthesia consultation in the investigator center For IgE group: \- presence of at least one positive skin...
You likely can't join if
- 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
See the full eligibility 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...
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Paris, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.