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Genetic study of perioperative anaphylaxis patients

Genetic study of perioperative anaphylaxis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089345
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Anaphylaxis

Interventions

Patients of perioperative anaphylaxis group:None
Healthy control group:None

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients group: 1. Patients visited the perioperative allergy clinic after July 2024, and their medical records indicated that they had experienced perioperative allergic reactions in the past; Or after January 2024, referred through the NPASI platform meet the clinical diagnostic criteria for perioperative anaphylaxis based on the judgment of researchers 2. Diagnosis of perioperative anaphylaxis corresponded to Ring and Messmer scale, which was recommended in several guidelines for classifying the immediate allergic reaction severity: (1) integumentary symptoms such as erythema, urticaria, mucosal changes of angioedema, or edema; (2) respiratory symptoms includes bronchospasm and airway obstruction in awake patients or increased airway pressures (peak=40mmHg) in ventilated patients; (3) cardiovascular changes, defined as hypotension, tachycardia, or cardiac arrest; (4) digestive system: nausea, vomiting or diarrhea. Two investigators made separate judgments on allergy cases, while a third researcher made the judgment for those with different opinions. 3. Patients show positive reaction to the suspected drug in either skin test or basophil activation test (BAT) to clarify the perioperative allergen. 4. Patients or their legal guardians have signed informed consent. Control group: (1) Patients who went to the anesthesia consultation clinic of China-Japan Friendship Hospital after July 2024 had previously undergone general anesthesia surgery, and there was no allergic reaction in the perioperative period; (2) No history of allergies in the past; (3) ASA classification I-III; (4) If the patient requests allergen testing due to a family history of allergies or other reasons, both the skin test and BAT test must be negative for the tested drug; (5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients group: 1. Patient cannot discontinue antihistamines or glucocorticoids or other drugs which may affect allergen test results; 2. Patient has severe immune system diseases, cardiovascular system diseases, or dermatologic diseases that affect allergen test results; 3. Patient has already been enrolled in other clinical trials; 4. The patient refuses to participate in the study or is unable to obtain peripheral blood samples from the patient; 5. The clinical symptoms of the patient include asthma attacks, hemorrhagic shock, excessive anesthesia, pulmonary embolism, and other non allergic diseases. Control group: (1) The patient refuses to participate in the study or is unable to obtain peripheral blood samples from the patient; (2) If the patient requests allergy testing and cannot discontinue drugs such as antihistamines or glucocorticoids that may affect the diagnostic test, or if the patient has severe immune system diseases, blood system diseases, or skin system diseases that may affect the allergen test results; (3) It has been included in other clinical trials.

Design outcomes

Primary

MeasureTime frame
DNA methylation of peripheral blood mononuclear cells;

Secondary

MeasureTime frame
MRGPRX2 gene sequence mutation;

Countries

China

Contacts

Public ContactJing Zhao

China-Japan Friendship Hospital

zhaojing1009@aliyun.com+86 10 8420 5876

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026