Clinical trial NCT06793163: Diagnosis and Allergen Identification of Perioperative Anaphylaxis
Official title: Diagnosis and Allergen Identification of Perioperative Anaphylaxis: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative/Postoperative Complications
Anaphylaxis
Tryptase
Allergens
Skin Testing
Keywords: Perioperative/Postoperative Complications
Anaphylaxis
Tryptase
Allergens
Skin Testing
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with suspected anaphylaxis in the operating room.

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of severe perioperative anaphylaxis
timeFrame: On the day of surgery in the operating room
Secondary outcomes:
measure: Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis.
timeFrame: On the day of surgery in the operating room
measure: Incidence of perioperative anaphylaxis
timeFrame: On the day of surgery in the operating room
measure: Allergen detection in patients with perioperative anaphlaxis
timeFrame: At least 4-6 weeks after the confirmed perioperative anaphylaxis
Other outcomes:
measure: Rate of surgical suspension due to suspected perioperative anaphylaxis.
timeFrame: On the day of surgery suspected perioperative anaphylaxis
measure: Rate of unplanned ICU admission due to suspected perioperative anaphylaxis
timeFrame: Within 24 hours of suspected perioperative anaphylaxis
measure: Rate of recurrence of perioperative anaphylaxis
timeFrame: On the day of surgery in the operating room
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.