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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
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Scientific title
Validation of the consensus clinical score for suspected preoperative immediate hypersensitivity reactions: a prospective observational trial.
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Secondary ID [1]
298855
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None
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Universal Trial Number (UTN)
U1111-1237-6029
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
anaphylaxis
313812
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Condition category
Condition code
Anaesthesiology
312221
312221
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0
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Anaesthetics
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Inflammatory and Immune System
312244
312244
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0
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Allergies
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
315122
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Diagnosis / Prognosis
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
320863
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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.
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Assessment method [1]
320863
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Timepoint [1]
320863
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At one point in time, 4 weeks to 3 months after anaphylaxis
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Primary outcome [2]
320891
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Specific IgE result to morphine, latex or chlorhexidine, taken at the time of clinic review.
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Assessment method [2]
320891
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Timepoint [2]
320891
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On once occasion, 4 weeks to 3 months after anaphylaxis
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Secondary outcome [1]
373117
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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
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Assessment method [1]
373117
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Timepoint [1]
373117
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On one occasion, 4 weeks to 3 months after reaction
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Eligibility
Key inclusion criteria
Referred to WA Anaesthetic Allergy Clinic within 2 months of a suspected preoperative hypersensitivity reaction.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Must have a full dataset for the consensus clinical score.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Case control
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Timing
Prospective
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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)
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/08/2019
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Actual
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Date of last participant enrolment
Anticipated
5/09/2019
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Actual
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Date of last data collection
Anticipated
8/10/2020
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
14318
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
27320
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
303404
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Hospital
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Name [1]
303404
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Sir Charles Gairdner Hospital
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Address [1]
303404
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Hospital Ave, Nedlands 6009 WA
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Country [1]
303404
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Australia
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Primary sponsor type
Hospital
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Name
Sir Charles Gairdner Hospital
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Address
Hospital Ave, Nedlands, Western Australia 6009
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Country
Australia
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Secondary sponsor category [1]
303447
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None
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Name [1]
303447
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Address [1]
303447
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Country [1]
303447
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303933
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Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
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Ethics committee address [1]
303933
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Hospital ave, Nedlands, Western Australia 6009
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Ethics committee country [1]
303933
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Australia
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Date submitted for ethics approval [1]
303933
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01/06/2019
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Approval date [1]
303933
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17/06/2019
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Ethics approval number [1]
303933
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32709
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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.
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Trial website
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Trial related presentations / publications
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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.
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Contacts
Principal investigator
Name
95302
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Dr Paul Sadleir
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Address
95302
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Sir Charles Gairdner Hospital, Nedlands Western Australia 6009.
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Country
95302
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Australia
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Phone
95302
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+61 421768082
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Fax
95302
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Email
95302
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[email protected]
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Contact person for public queries
Name
95303
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Dr Paul Sadleir
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Address
95303
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Sir Charles Gairdner Hospital, Nedlands Western Australia 6009.
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Country
95303
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Australia
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Phone
95303
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+61 421768082
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Fax
95303
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Email
95303
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[email protected]
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Contact person for scientific queries
Name
95304
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Dr Paul Sadleir
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Address
95304
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Sir Charles Gairdner Hospital, Nedlands Western Australia 6009.
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Country
95304
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Australia
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Phone
95304
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+61 421768082
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Fax
95304
0
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Email
95304
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
patient confidentiality
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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
Source
Title
Year of Publication
DOI
Embase
Agreement of a clinical scoring system with allergic anaphylaxis in suspected perioperative hypersensitivity reactions: prospective validation of a new tool.
2022
https://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.
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