Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001117707p
Ethics application status
Submitted, not yet approved
Date submitted
28/07/2022
Date registered
12/08/2022
Date last updated
12/08/2022
Date data sharing statement initially provided
12/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Colours’: Skin testing as a new technique of estimating the comparative risk of anaphylaxis to neuromuscular blocking agents by consideration of cross-reactivity.
Scientific title
‘Colours’: Skin testing as a new technique of estimating the comparative risk of anaphylaxis to neuromuscular blocking agents in adults with known NMBA anaphylaxis by consideration of cross-reactivity.
Secondary ID [1] 307673 0
Nil known
Universal Trial Number (UTN)
U1111-1281-0064
Trial acronym
Colours
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaphylaxis 327206 0
Condition category
Condition code
Anaesthesiology 324345 324345 0 0
Anaesthetics
Inflammatory and Immune System 324346 324346 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational only. Patients will undergo skin testing regardless of participation in this trial.
Patients will not have any change in involvement based on participation in this study. Their data that would normally be collected will just be analysed in a novel fashion.
Patients already seen in the clinic will be retrospectively analysed from the period 2000-2021.
Data collection: sex, age, severity of reaction, disposition, mast cell tryptase, surgery completed or abandoned.
Intervention code [1] 324149 0
Diagnosis / Prognosis
Comparator / control treatment
Comparing the pattern of cross-reactivity in cases of rocuronium and vecuronium anaphylaxis to determine the population exposure rates to each.
The comparator will be the relative rate of anaphylaxis to each agent as determined by literature review (prescription-event monitoring methods).
Comparison is being made between rocuronium and vecuronium groups with respect to factors in the previous entry: sex, age, severity of reaction, disposition, mast cell tryptase, surgery completed or abandoned.
Control group
Active

Outcomes
Primary outcome [1] 332149 0
Outcome is pattern of cross-reactivity to either agent as assessed by skin testing. A patient will be deemed hypersensitive if they have a wheal on skin testing of greater than 8mm in diameter.
Cross-sensitivity rate will be determined as the proportion of participants who have a positive skin test result (longest wheal diameter >8mm) to one or 2 neuromuscular blocking agents assessed by the medical record.
Timepoint [1] 332149 0
At time of review of the medical record.
Secondary outcome [1] 412382 0
Differences in severity of reaction of patients who are hypersensitive to only one agent will be compared to those who are hypersensitive to both agents as compared to just one agent..
Timepoint [1] 412382 0
At time of review of the medical record.
Secondary outcome [2] 412782 0
Differences in sex of patients who are hypersensitive to only one agent will be compared to those who are hypersensitive to both agents as compared to just one agent..
Timepoint [2] 412782 0
At time of review in clinic as recorded in medical record

Eligibility
Key inclusion criteria
Adults having anaphylaxis to rocuronium or vecuronium
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The proportion of patients with a history of anaphylaxis to each agent will be compared in the subgroup of patients hypersensitive to both agents. This will be used to estimate the relative prescription rate. This will then be used to correct the observed number of cases of each agent to give a relative risk of anaphylaxis.
This will be compared to the historical risk of anaphylaxis to each agent as determined by PEM from a literature review.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/08/2022
Actual
Date of last participant enrolment
Anticipated
22/08/2022
Actual
Date of last data collection
Anticipated
22/08/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22888 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38193 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 311944 0
Hospital
Name [1] 311944 0
Sir Charles Gairdner Hospital
Country [1] 311944 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Monash Ave
Nedlands 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 313427 0
None
Name [1] 313427 0
Address [1] 313427 0
Country [1] 313427 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311373 0
Sir Charles Gairdner Osbourne Park Hospital ethics commiteee
Ethics committee address [1] 311373 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands 6009, Western Australia
Ethics committee country [1] 311373 0
Australia
Date submitted for ethics approval [1] 311373 0
11/08/2022
Approval date [1] 311373 0
Ethics approval number [1] 311373 0

Summary
Brief summary
Rates of cross-reactivity to rocuronium and vecuronium can be used to estimate population exposure and therefore correct individual rates to exposure to give a risk per dose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120874 0
Dr Paul Sadleir
Address 120874 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands 6009, Western Australia
Country 120874 0
Australia
Phone 120874 0
+61421768082
Fax 120874 0
Email 120874 0
paul.sadleir@uwa.edu.au
Contact person for public queries
Name 120875 0
Dr Paul Sadleir
Address 120875 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands 6009, Western Australia
Country 120875 0
Australia
Phone 120875 0
+61 8 64573333
Fax 120875 0
Email 120875 0
paul.sadleir@uwa.edu.au
Contact person for scientific queries
Name 120876 0
Dr Paul Sadleir
Address 120876 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands 6009, Western Australia
Country 120876 0
Australia
Phone 120876 0
+61 64573333
Fax 120876 0
Email 120876 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
No infrastructure to do so


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
No additional documents have been identified.