Actively Recruiting

Age: 2Years +
All Genders
ID06793163

Diagnosis and Allergen Identification of Perioperative Anaphylaxis: a Multicenter Prospective Cohort Study

Led by Peking University First Hospital · Updated on 2025-11-24

115

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Perioperative anaphylaxis, a rare but potentially fatal reaction during surgery, is difficult to diagnose and manage due to the complex combination of anesthetic drugs, medications, and surgical effects. This research aims to better understand perioperative anaphylaxis by measuring serum tryptase levels, which help distinguish anaphylaxis from other causes, and by identifying allergens that trigger these reactions using skin tests. The study is a multicenter prospective cohort designed to clarify the incidence and allergen causes of suspected perioperative anaphylaxis cases. The study involves patients aged 2 years and older who have suspected perioperative anaphylaxis during surgery or have a history of such events. Serum samples for tryptase level will be collected promptly after symptom onset and repeated 24 hours later to assist diagnosis. Skin prick and intradermal tests will be performed 4 to 6 weeks after the anaphylaxis event to identify the specific allergens responsible. Participants will be observed on the day of surgery in the operating room, with primary outcomes including the incidence of severe perioperative anaphylaxis. Secondary outcomes include diagnostic rates and allergen detection results. The study is observational, without interventional treatments, and participants’ health and reactions will be closely monitored through blood tests and skin testing over weeks. The study ensures careful evaluation of allergic reactions to improve future management and safety during surgeries.

CONDITIONS

Brief Title

Diagnosis and Allergen Identification of Perioperative Anaphylaxis

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 2 years or over
  • Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room
Not Eligible

You will not qualify if you...

  • Refuse to participate
  • Other conditions that are considered unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants with suspected perioperative anaphylaxis have serum samples collected for tryptase detection shortly after symptom onset and again 24 hours later to help confirm the diagnosis.

1 to 2 visits (in-person) on the day of surgery

Long-term Monitoring

Duration - 4 to 6 weeks after anaphylaxis

Participants undergo skin testing including skin prick tests and intradermal tests to identify allergens, performed 4 to 6 weeks after the suspected perioperative anaphylaxis event.

1 visit (in-person)

Trial Site Locations

Total: 5 locations

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

2

Beijing Anorectal Hospital (Beijing Erlong Road Hospital)

Beijing, Beijing Municipality, China

Actively Recruiting

3

Beijing Children's Hospital, Capital Medical University; National Center for Children's Health, China

Beijing, Beijing Municipality, China

Actively Recruiting

4

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Actively Recruiting

5

Peking University First Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD, PhD

Y

Ya-Wei Li, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Australian and New Zealand Anaesthetic Allergy Group/Australian and New Zealand College of Anaesthetists perioperative anaphylaxis management guideline 2022.

Robyn Tran, Karen Pedersen, Helen Kolawole...

https://pubmed.ncbi.nlm.nih.gov/38587791