Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001104145
Ethics application status
Approved
Date submitted
25/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Risk factors for intraoperative anaphylaxis to muscle relaxants: a case-control study.
Scientific title
Risk factors for intraoperative anaphylaxis to muscle relaxants: a case-control study.
Secondary ID [1] 298841 0
None
Universal Trial Number (UTN)
U1111-1237-5570
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraoperative anaphylaxis 313792 0
Obesity 313793 0
Pholcodine consumption 313794 0
Condition category
Condition code
Anaesthesiology 312207 312207 0 0
Anaesthetics
Diet and Nutrition 312245 312245 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study involves interrogation of the Western Australian Anaesthetic Allergy Clinic Database (patient questionnaire, medical records and outcome of skin testing and blood tests). Exposure is the patient characteristics that may predispose to anaphylaxis (body mass index, gender, age, pholcodine exposure, ASA grade). Duration of observation is 6 months previous to anaphylactic reaction
Intervention code [1] 315106 0
Diagnosis / Prognosis
Comparator / control treatment
Condition observed is either muscle relaxant anaphylaxis or cephazolin anaphylaxis. All cases must have been administered a muscle relaxant during the course of the anaesthetic in which anaphylaxis occurred.
Control group
Active

Outcomes
Primary outcome [1] 320837 0
Obesity as assessed by audit of Western Australian Allergy Clinic Database
Timepoint [1] 320837 0
At time of diagnosis of anaphylactic trigger
Primary outcome [2] 320893 0
Pholcodine exposure as assessed by audit of Western Australian Allergy Clinic Database
Timepoint [2] 320893 0
In the 6 months prior to the anaphylactic reaction
Secondary outcome [1] 373002 0
Severity of anaphylaxis between cases and controls (grade of anaphylaxis, proportion in which surgery abandoned, proportion requiring ICU admission, peak mast cell tryptase), as assessed by audit of Western Australian Allergy Clinic Database
Timepoint [1] 373002 0
at time of reaction

Eligibility
Key inclusion criteria
Inclusion criteria are intraoperative anaphylaxis in patients all of whom were exposed to a muscle relaxant during the intraoperative episode, prior to the reaction. Recruited patients either had anaphylaxis to a muscle relaxant or cephazolin
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Must be over 18, and must be able to be contacted to confirm Pholcodine exposure if not documented previously. BMI must have been documented at time of reaction or review in clinic as long as that was within 3 months of the reaction. Skin testing must have occurred within 5 years of intraoperative reaction.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
Case control study, sample size estimate 150 patients (2:1 cases:controls, based on prevalence of obesity estimated at 30% in controls, expected OR 2-3).
Multiple variable analysis by logistic regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2019
Actual
Date of last participant enrolment
Anticipated
30/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 27313 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303390 0
Hospital
Name [1] 303390 0
Sir Charles Gairdner Hospital
Country [1] 303390 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave, Nedlands 6009 WA
Country
Australia
Secondary sponsor category [1] 303427 0
None
Name [1] 303427 0
None
Address [1] 303427 0
None
Country [1] 303427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303919 0
Sir Charles Gairdner Hospital Research Ethics Committee
Ethics committee address [1] 303919 0
Hospital Ave, Nedlands, Western Australia 6009.
Ethics committee country [1] 303919 0
Australia
Date submitted for ethics approval [1] 303919 0
Approval date [1] 303919 0
05/10/2017
Ethics approval number [1] 303919 0
Q15703

Summary
Brief summary
This study is designed to measure the risk factors that are important in the development of muscle relaxant anaphylaxis. It does this by comparing risk factors between two similar groups of patients that have had anaphylaxis, the only difference being that one group suffered anaphylaxis to a muscle relaxant, the other to cephazolin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95250 0
Dr Paul Sadleir
Address 95250 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, Western Australia 6009.
Country 95250 0
Australia
Phone 95250 0
+61 8 64313333
Fax 95250 0
Email 95250 0
paul.sadleir@uwa.edu.au
Contact person for public queries
Name 95251 0
Dr Paul Sadleir
Address 95251 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, Western Australia 6009.
Country 95251 0
Australia
Phone 95251 0
+61 8 64313333
Fax 95251 0
Email 95251 0
paul.sadleir@uwa.edu.au
Contact person for scientific queries
Name 95252 0
Dr Paul Sadleir
Address 95252 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, Western Australia 6009.
Country 95252 0
Australia
Phone 95252 0
+61 8 64313333
Fax 95252 0
Email 95252 0
paul.sadleir@uwa.edu.au

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


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
EmbaseRelationship of perioperative anaphylaxis to neuromuscular blocking agents, obesity, and pholcodine consumption: a case-control study.2021https://dx.doi.org/10.1016/j.bja.2020.12.018
N.B. These documents automatically identified may not have been verified by the study sponsor.