Diagnosis and Allergen Identification of Perioperative Anaphylaxis

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

Perioperative anaphylaxis may lead to fatal respiratory and/or circulatory events, yet both clinical diagnosis and management are challenging. Serum tryptase is an indicator that can provide important retrospective diagnostic value for anaphylaxis. Another key point in perioperative anaphylaxis management is to identify the allergens, and thus avoid re-exposure during later perioperative management. Skin testing is an important way to identify allergens.

Study Overview

• Status: Recruiting
• Conditions: Perioperative/Postoperative Complications; Anaphylaxis; Tryptase; Skin Testing; Allergens

Detailed Description

Perioperative anaphylaxis are rare, but may be fatal. The combined use of anesthetic drugs and other medications, and the additional effects of surgical procedures, make the diagnosis and differential diagnosis rather complicated. Subsequent allergy investigations and allergen identification are often difficult.

The change of tryptase levels is an important biomarker in differentiating anaphylaxis from other causes. It is recommended that, in case of any suspicion of perioperative anaphylaxis, serum samples for tryptase detection should be collected as soon as possible after the onset of symptoms and then repeated 24 h later. Skin testing including skin prick tests (SPT) and intradermal tests (IDT) is universally used in identifying allergens. Skin testing will be performed 4-6 weeks after the onset of perioperative anaphylaxis.

This prospective cohort study is designed to clarify the rate of perioperative anaphylaxis with testing serum tryptase level and to identify the underlying allergens by conducting skin testing in surgical patients with suspected perioperative anaphylaxis.

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Dong-Xin Wang, MD, PhD; Phone Number: 86-10-83572784; Email: wangdongxin@hotmail.com
• Study Contact Backup: Name: Ya-Wei Li, MD; Phone Number: 86-10-83572460; Email: liyawei@bjmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Ya-Wei Li; Phone Number: 086-010-83572460; Email: liyawei@bjmu.edu.cn
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University First Hospital
      • Contact: Ya-Wei Li; Phone Number: 086-83575138; Email: liyawei@bjmu.edu.cn
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Children's Hospital, Capital Medical University; National Center for Children's Health, China
      • Contact: Doctor Gao; Phone Number: 086-010-59616415; Email: jiajia071@sina.com
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: ling Xiong; Phone Number: 086-010-63014411; Email: Lynnxiong@foxmail.com
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Anorectal Hospital (Beijing Erlong Road Hospital）
      • Contact: Jian-Hu Doctor Yuan; Phone Number: 086-010-57763201; Email: yjhu585@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with suspected anaphylaxis in the operating room.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Suspected anaphylaxis; Adult patients with suspected anaphylaxis in the operating rooms, or with history of suspected anaphylaxis in the operating room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe perioperative anaphylaxis	Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. Severe perioperative anaphylaxis indicates grade 3 or above according to the World Allergy Organization systemic allergic reaction grading system. The incidence is calculated as the number of cases with severe perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.	On the day of surgery in the operating room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis.	Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The rate is calculated as the number of cases with confirmed anaphylaxis divided by the total number of cases with suspected anaphylaxis in the operating room during the study period.	On the day of surgery in the operating room
Incidence of perioperative anaphylaxis	Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The incidence is calculated as the number of cases with any grade perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.	On the day of surgery in the operating room
Allergen detection in patients with perioperative anaphlaxis	Allergen is detected with skin testing in patients with confirmed perioperative anaphylaxis. Skin testing will be performed at least 4-6 weeks after the confirmed anaphylaxis.	At least 4-6 weeks after the confirmed perioperative anaphylaxis

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of surgical suspension due to suspected perioperative anaphylaxis.	The rate is calculated as the number of patients with surgical suspension due to suspected perioperative anaphylaxis divided by the total number of patients with suspected/confirmed perioperative anaphylaxis in the operating room during the study period.	On the day of surgery suspected perioperative anaphylaxis
Rate of unplanned ICU admission due to suspected perioperative anaphylaxis	The rate is calculated as the number of patients with unplanned ICU admission due to suspected perioperative anaphylaxis divided by the total number of patients with suspected/confirmed perioperative anaphylaxis in the operating room during the study period.	Within 24 hours of suspected perioperative anaphylaxis
Rate of recurrence of perioperative anaphylaxis	Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The rate is calculated as the number of patients with recurrence of suspected perioperative anaphylaxis divided by the total number of patients with confirmed perioperative anaphylaxis in the operating room during the study period.	On the day of surgery in the operating room

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

General Publications

• Muraro A, Worm M, Alviani C, Cardona V, DunnGalvin A, Garvey LH, Riggioni C, de Silva D, Angier E, Arasi S, Bellou A, Beyer K, Bijlhout D, Bilo MB, Bindslev-Jensen C, Brockow K, Fernandez-Rivas M, Halken S, Jensen B, Khaleva E, Michaelis LJ, Oude Elberink HNG, Regent L, Sanchez A, Vlieg-Boerstra BJ, Roberts G; European Academy of Allergy and Clinical Immunology, Food Allergy, Anaphylaxis Guidelines Group. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022 Feb;77(2):357-377. doi: 10.1111/all.15032. Epub 2021 Sep 1.
• Tran R, Pedersen K, Kolawole H, Roessler P, Scolaro R. Australian and New Zealand Anaesthetic Allergy Group/Australian and New Zealand College of Anaesthetists perioperative anaphylaxis management guideline 2022. Anaesth Intensive Care. 2024 May;52(3):147-158. doi: 10.1177/0310057X231215823. Epub 2024 Apr 8.
• Manian DV, Volcheck GW. Perioperative Anaphylaxis: Evaluation and Management. Clin Rev Allergy Immunol. 2022 Jun;62(3):383-399. doi: 10.1007/s12016-021-08874-1. Epub 2021 Jul 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Perioperative/Postoperative Complications; Anaphylaxis; Tryptase; Allergens; Skin Testing
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Anaphylaxis
• Other Study ID Numbers: 2024-620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No