Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001496707p
Ethics application status
Not yet submitted
Date submitted
23/11/2022
Date registered
29/11/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine how common anaemia is in children having major surgery.
Scientific title
A retrospective observational study of preoperative anaemia in paediatric patients undergoing major surgery.
Secondary ID [1] 308478 0
Nil known
Universal Trial Number (UTN)
U1111-1285-3731
Trial acronym
ROAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 328291 0
Perioperative Anaemia 328292 0
Condition category
Condition code
Blood 325337 325337 0 0
Anaemia
Anaesthesiology 325338 325338 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective observational study to determine the prevalence of anaemia (as defined by the World Health Organisation) in paediatric patients undergoing elective or emergency major surgery in a single tertiary centre in New Zealand.

Medical records for all patients undergoing major surgery between 01/01/2021 and 01/01/2022 will be analysed, and those with a full blood count within 3 months prior to surgery recruited. As well as haemoglobin concentration prior to surgery, researchers will collect ferritin concentration, creatinine concentration, folate/B12 concentration, gender, age, weight, ethnicity, ASA score, surgical priority, type of surgery, the presence of significant comorbidities, intraoperative and postoperative blood transfusions, length of stay in hospital, and 30 day mortality.

Data collected for each participant will pertain to a single admission episode.
Intervention code [1] 324923 0
Diagnosis / Prognosis
Comparator / control treatment
Patients in the study population will be divided into anaemic and non-anaemic, and comparisons of outcomes made between the two.
Control group
Active

Outcomes
Primary outcome [1] 333200 0
Prevalence of anaemia as a percentage, as defined by WHO threshholds, from electronic patient record
Timepoint [1] 333200 0
Within 3 months prior to surgery
Primary outcome [2] 333201 0
Red blood cell transfusion rate as a percentage from electronic patient record
Timepoint [2] 333201 0
During surgical admission episode
Secondary outcome [1] 416122 0
All cause mortality as recorded in electronic patient record
Timepoint [1] 416122 0
Within 30 days of index surgical procedure
Secondary outcome [2] 416123 0
Ferritin concentration from electronic patient record
Timepoint [2] 416123 0
Within 3 months prior to surgery
Secondary outcome [3] 416124 0
Vitamin B12 concentration from electronic patient record
Timepoint [3] 416124 0
Within 3 months prior to surgery
Secondary outcome [4] 416125 0
Folate concentration from electronic patient record
Timepoint [4] 416125 0
Within 3 months prior to surgery
Secondary outcome [5] 416126 0
Creatinine concentration from electronic patient record
Timepoint [5] 416126 0
Within 3 months prior to surgery
Secondary outcome [6] 416127 0
Duration of surgical admission from electronic patient record
Timepoint [6] 416127 0
During surgical admission episode
Secondary outcome [7] 416128 0
Incidence of post operative complications (anaemia as defined by WHO, new infection requiring antimicrobial therapy, new thromboembolic event, new renal failure) as documented in the electronic patient record and patient electronic discharge summary for the surgical admission.
Timepoint [7] 416128 0
During surgical admission episode
Secondary outcome [8] 416302 0
Red blood cell transfusion per kilogram body weight, from the electronic patient record
Timepoint [8] 416302 0
During surgical admission episode

Eligibility
Key inclusion criteria
All patients > 6 months and < 16 years undergoing major surgery between 01/01/2021 at 01/01/2022.
Minimum age
6 Months
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 6 months or > 16 years.
Blood transfusion within 7 days prior to surgery.
No preoperative haemoglobin concentration available in the 3 month period prior to surgery.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Prevalence of anaemia in the general New Zealand paediatric population is estimated at 15%. Previously published studies of pre-operative anaemia in paediatric surgical patients in developed countries have described a prevalence between 24-46%. A sample size of 250 patients will have a precision of ±5% if observed prevalence is 20%, and ±6% if observed prevalence is 50%, with 95% confidence. Approximately 6 patients per week undergo major surgery at this centre, so collection of data over a 1 year period should ensure an adequate number of patients recruited.

Statistical methodology for this study has been discussed with a statistician prior to commencement. Statistician input will be sought for analysis of the final data.
Demographics and outcomes will be presented as frequencies and percentages for discrete variables, and median with interquartile range or mean (SD) for continuous variables. Discrete variables will be analysed with Chi-squared or Fisher’s exact tests where appropriate. Continuous variables will be analysed with either a two-sided Wilcoxon rank-sum test or Student’s t test after testing for normality. Missing data will be reported.

The following will be calculated:
Prevalence of anaemia as a percentage
Prevalence of red blood cell transfusion as a percentage
Volume of red blood cell transfused per kilogram body weight

Independent variables associated with anaemia will be investigated.
Outcomes will be compared between anaemic and non-anaemic patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/03/2023
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 25154 0
New Zealand
State/province [1] 25154 0
Auckland

Funding & Sponsors
Funding source category [1] 312720 0
Hospital
Name [1] 312720 0
Department of Anaesthesia, Starship Children's Hospital
Country [1] 312720 0
New Zealand
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Starship Children's Hospital
Address
2 Park Road,
Grafton,
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 314344 0
None
Name [1] 314344 0
Address [1] 314344 0
Country [1] 314344 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312021 0
The Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 312021 0
Ethics committee country [1] 312021 0
New Zealand
Date submitted for ethics approval [1] 312021 0
01/12/2022
Approval date [1] 312021 0
Ethics approval number [1] 312021 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123202 0
Dr Matthew Hart
Address 123202 0
Starship Children's Hospital
2 Park Road,
Grafton,
Auckland 1023
Country 123202 0
New Zealand
Phone 123202 0
+64 9 367 0000
Fax 123202 0
Email 123202 0
[email protected]
Contact person for public queries
Name 123203 0
Caroline Mann
Address 123203 0
Starship Children's Hospital
2 Park Road,
Grafton,
Auckland 1023
Country 123203 0
New Zealand
Phone 123203 0
+64 9 367 0000
Fax 123203 0
Email 123203 0
[email protected]
Contact person for scientific queries
Name 123204 0
Caroline Mann
Address 123204 0
Starship Children's Hospital
2 Park Road,
Grafton,
Auckland 1023
Country 123204 0
New Zealand
Phone 123204 0
+64 9 367 0000
Fax 123204 0
Email 123204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning immediately following publication and ending 10 years following publication of main results.
Available to whom?
Published data will only be available to approved researchers after approval by the Principal Investigator and under specific data-sharing arrangements arranged through the Starship Research & Innovation Office.
Available for what types of analyses?
Data will be made available for research on perioperative anaemia.
How or where can data be obtained?
Published data will only be available to approved researchers after approval by the Principal Investigator and under specific data-sharing arrangements arranged through the Starship Research & Innovation Office. This can be requested by emailing [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17694Study protocol  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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