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Evaluation of passive mast cell activation test in the diagnosis of perioperative allergens

Innovation and clinical transformation of in vitro diagnosis of perioperative anaphylaxis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084268
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-05-20
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Perioperative anaphylaxis

Interventions

Gold Standard:Skin test and/or basophil activation test
Index test:Passive mast cell activation test

Sponsors

China-japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with PA may exhibit various clinical manifestations within 15 minutes after the administration of anesthetic drugs during the perioperative period. These manifestations include: 1.Circulatory system: hypotension (systolic blood pressure = 70 mmHg), tachycardia (heart rate = 110 beats/min), or rapid progression to serious arrhythmia, circulatory failure, or cardiac arrest.; 2.Respiratory system: increased secretion of saliva and sputum, laryngospasm, bronchospasm, increased airway pressure (peak airway pressure = 40 mmHg), wheezing, moist rales in the lungs, and hypoxemia (SpO2 = 90%); 3.Digestive system: nausea, vomiting or diarrhea; 4.Skin and mucosa: skin flushing, various rashes (especially wind blot-like papules), subcutaneous angioedema, systemic skin edema, and edema of nasal, eye, and throat mucosa;

Exclusion criteria

Exclusion criteria: 1.Cases with systemic manifestations meeting the inclusion criteria but failing to make differential diagnosis from non-allergic diseases such as asthma attack, hemorrhagic shock, deep anesthesia, or pulmonary embolism. 2.Patients who are unable to discontinue antihistamines or glucocorticoids when BAT or pMAT are needed, as they may affect results; 3.Patients with severe immune system diseases, hematological system diseases, or skin diseases that could impact the allergen detection results; 4.Anaphylaxis occurring within 4-6 weeks prior to participating in the trial; 5.Patients who decline to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Proportion of mast cells activated;

Secondary

MeasureTime frame
Accuracy;sensitivity;false negative rate;Area under ROC curve;

Countries

China

Contacts

Public ContactZhao Jing

China-japan Friendship Hospital

zhaojing1009@aliyun.com+86 139 0104 8114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 27, 2026