Finding causes of allergic reactions during and after surgery
Diagnosis and Allergen Identification of Perioperative Anaphylaxis: a Multicenter Prospective Cohort Study
This project tests whether measuring tryptase levels and doing skin tests can find the cause of suspected allergic reactions during or after surgery for patients aged 2 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Trial ID | NCT06793163 on ClinicalTrials.gov |
What this trial studies
This is a prospective cohort across several Beijing hospitals enrolling surgical patients with suspected perioperative anaphylaxis. Blood samples for serum tryptase are collected as soon as possible after the event and repeated about 24 hours later, and skin prick and intradermal tests are performed 4–6 weeks afterward to identify specific allergens. The study quantifies the rate of perioperative anaphylaxis and links tryptase dynamics to confirmed allergen sensitization. Patients who refuse or are judged unsuitable for participation are excluded.
Who should consider this trial
Good fit: Surgical patients aged 2 years or older who experienced a suspected allergic reaction in the operating room or perioperative period are the intended participants.
Not a fit: People without suspected perioperative allergic reactions, those unable or unwilling to undergo blood draws or delayed skin testing, or reactions not driven by an allergic mechanism are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could help clinicians more reliably diagnose perioperative anaphylaxis and identify offending drugs or agents so they can be avoided in future procedures.
How similar studies have performed: Measuring serum tryptase and performing skin prick/intradermal tests are established diagnostic tools with supporting evidence, though prospective cohorts focused on perioperative cases are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 2 years or over; * Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room. Exclusion Criteria: * Refuse to participate; * Other conditions that are considered unsuitable for study participation.
Where this trial is running
Beijing, Beijing Municipality and 4 other locations
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Anorectal Hospital (Beijing Erlong Road Hospital） — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Children's Hospital, Capital Medical University; National Center for Children's Health, China — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD, PhD
- Email: wangdongxin@hotmail.com
- Phone: 86-10-83572784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.