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Trial registered on ANZCTR


Registration number
ACTRN12619001132134
Ethics application status
Approved
Date submitted
26/07/2019
Date registered
13/08/2019
Date last updated
13/08/2019
Date data sharing statement initially provided
13/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a clinical score identifying cases of preoperative anaphylaxis
Scientific title
Validation of the consensus clinical score for suspected preoperative immediate hypersensitivity reactions: a prospective observational trial.
Secondary ID [1] 298855 0
None
Universal Trial Number (UTN)
U1111-1237-6029
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaphylaxis 313812 0
Condition category
Condition code
Anaesthesiology 312221 312221 0 0
Anaesthetics
Inflammatory and Immune System 312244 312244 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be classified according to the consensus clinical scoring system for preoperative immediate hypersensitivity reactions into grades of probability of IgE-mediated anaphylaxis. Participation in the study does not involve any intervention that is not part of routine clinical care, but involves out routine request for access to records, blood tests and our clinical history questionnaire. Study will be completed in 2019-2020.
Intervention code [1] 315122 0
Diagnosis / Prognosis
Comparator / control treatment
The Grading according to the score will be compared to expert opinion of a clinician panel and subsequent skin and in-vitro test results.
Control group
Active

Outcomes
Primary outcome [1] 320863 0
The outcome is presence or absence of positive skin test result. A positive skin test result is an 8mm wheal with flare after 0.02-0.03ml of diluted antigen injected intradermally.
Timepoint [1] 320863 0
At one point in time, 4 weeks to 3 months after anaphylaxis
Primary outcome [2] 320891 0
Specific IgE result to morphine, latex or chlorhexidine, taken at the time of clinic review.
Timepoint [2] 320891 0
On once occasion, 4 weeks to 3 months after anaphylaxis
Secondary outcome [1] 373117 0
Difference in exposure to pholcodine between patients with muscle relaxant anaphylaxis and other patient groups. Pholcodine is defined as consumption within 6 months of the anaphylactic reaction
Timepoint [1] 373117 0
On one occasion, 4 weeks to 3 months after reaction

Eligibility
Key inclusion criteria
Referred to WA Anaesthetic Allergy Clinic within 2 months of a suspected preoperative hypersensitivity reaction.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Must have a full dataset for the consensus clinical score.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Each outcome of the clinical consensus score will be assessed for sensitivity and specificity in predicting a positive skin test result, including the generation of receiver operator curves. Same will be repeated for in-vitro tests, and with and without an acute and baseline mast cell tryptase.
Outcome of the clinical consensus score will be compared to predictions of an expert clinician panel (blinded to results of skin testing)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2019
Actual
Date of last participant enrolment
Anticipated
5/09/2019
Actual
Date of last data collection
Anticipated
8/10/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14318 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 27320 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303404 0
Hospital
Name [1] 303404 0
Sir Charles Gairdner Hospital
Country [1] 303404 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave, Nedlands, Western Australia 6009
Country
Australia
Secondary sponsor category [1] 303447 0
None
Name [1] 303447 0
Address [1] 303447 0
Country [1] 303447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303933 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 303933 0
Hospital ave, Nedlands, Western Australia 6009
Ethics committee country [1] 303933 0
Australia
Date submitted for ethics approval [1] 303933 0
01/06/2019
Approval date [1] 303933 0
17/06/2019
Ethics approval number [1] 303933 0
32709

Summary
Brief summary
This study attempts to validate or invalidate the consensus clinical scoring system for preoperative hypersensitivity reactions, comparing the results of the score to an expert clinician panel, and to the subsequent results of skin tests and in-vitro results.
Trial website
Trial related presentations / publications
Public notes
The Western Australian Anaesthetic Allergy Clinic patient information database and clinical protocol was updated in November 2018 to reflect best clinical practice. Permission to use prospectively collected data for research and publication was approved in June, 2019.

Contacts
Principal investigator
Name 95302 0
Dr Paul Sadleir
Address 95302 0
Sir Charles Gairdner Hospital, Nedlands Western Australia 6009.
Country 95302 0
Australia
Phone 95302 0
+61 421768082
Fax 95302 0
Email 95302 0
[email protected]
Contact person for public queries
Name 95303 0
Paul Sadleir
Address 95303 0
Sir Charles Gairdner Hospital, Nedlands Western Australia 6009.
Country 95303 0
Australia
Phone 95303 0
+61 421768082
Fax 95303 0
Email 95303 0
[email protected]
Contact person for scientific queries
Name 95304 0
Paul Sadleir
Address 95304 0
Sir Charles Gairdner Hospital, Nedlands Western Australia 6009.
Country 95304 0
Australia
Phone 95304 0
+61 421768082
Fax 95304 0
Email 95304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
patient confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAgreement of a clinical scoring system with allergic anaphylaxis in suspected perioperative hypersensitivity reactions: prospective validation of a new tool.2022https://dx.doi.org/10.1016/j.bja.2022.07.034
N.B. These documents automatically identified may not have been verified by the study sponsor.