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Recruiting NCT06793163

Diagnosis and Allergen Identification of Perioperative Anaphylaxis

— Observational Perioperative/Postoperative Complications Anaphylaxis Tryptase Allergens

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Perioperative/Postoperative Complications, Anaphylaxis, Tryptase, Allergens. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Incidence of severe perioperative anaphylaxis [Time frame: On the day of surgery in the operating room]
Secondary outcome measures (3)
  • Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis. [Time frame: On the day of surgery in the operating room]
  • Incidence of perioperative anaphylaxis [Time frame: On the day of surgery in the operating room]
  • Allergen detection in patients with perioperative anaphlaxis [Time frame: At least 4-6 weeks after the confirmed 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 6 centers
  • Peking University First Hospital — Beijing
  • Beijing Anorectal Hospital (Beijing Erlong Road Hospital） — Beijing
  • Beijing Children's Hospital, Capital Medical University; National Center for Children's He — Beijing
  • Beijing Friendship Hospital, Capital Medical University — Beijing
  • Beijing Tongren Hospital, Capital Medical University — Beijing
  • Peking University First Hospital — Beijing

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 Guideline PMID 34343358
  • 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. PMID 38587791
  • 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. PMID 34247332

Identifiers

NCT: NCT06793163 · 2024-620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗