ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Perioperative Anaemia

Condition category

Condition code

Blood

Anaemia

Anaesthesiology

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]

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]

Prevalence of anaemia as a percentage, as defined by WHO threshholds, from electronic patient record

Timepoint [1]

Within 3 months prior to surgery

Primary outcome [2]

Red blood cell transfusion rate as a percentage from electronic patient record

Timepoint [2]

During surgical admission episode

Secondary outcome [1]

All cause mortality as recorded in electronic patient record

Timepoint [1]

Within 30 days of index surgical procedure

Secondary outcome [2]

Ferritin concentration from electronic patient record

Timepoint [2]

Within 3 months prior to surgery

Secondary outcome [3]

Vitamin B12 concentration from electronic patient record

Timepoint [3]

Within 3 months prior to surgery

Secondary outcome [4]

Folate concentration from electronic patient record

Timepoint [4]

Within 3 months prior to surgery

Secondary outcome [5]

Creatinine concentration from electronic patient record

Timepoint [5]

Within 3 months prior to surgery

Secondary outcome [6]

Duration of surgical admission from electronic patient record

Timepoint [6]

During surgical admission episode

Secondary outcome [7]

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]

During surgical admission episode

Secondary outcome [8]

Red blood cell transfusion per kilogram body weight, from the electronic patient record

Timepoint [8]

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?

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia, Starship Children's Hospital

Address [1]

2 Park Road,
Grafton,
Auckland 1023

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Auckland Health Research Ethics Committee (AHREC)

Ethics committee address [1]

The University of Auckland
Private Bag 92019
Auckland 1142

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/12/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Anaemia is a common problem worldwide. In the perioperative setting, it has been identified as a predictor of morbidity and mortality in both adults and children. Anaemic patients undergoing surgery often require transfusion of autologous blood products in the perioperative period, which carries both a risk of morbidity and increased healthcare costs. For these reasons, patient blood management programmes have been developed internationally which emphasise diagnosis and treatment of preoperative anaemia with the aim of improving outcomes and reducing costs in the adult surgical population.
The prevalence of preoperative anaemia in the paediatric surgical population is poorly described in the literature, and the current prevalence of anaemia in children undergoing major elective surgery in New Zealand is unknown. Some pathologies requiring major surgery in children disproportionately affect groups at higher risk of anaemia, such as postmenarchal adolescent females undergoing surgical correction of idiopathic scoliosis. Recent studies suggest that anaemia in the general paediatric population in New Zealand is common, and disproportionately affects those of Maori and Pacific ethnicity. A better understanding of preoperative anaemia as a clinical entity in the paediatric surgical population in New Zealand will allow an opportunity to improve quality of clinical care, and develop strategies to target any inherent inequities in our current system.

This study aims to:
-	Quantify the prevalence of preoperative anaemia in paediatric patients undergoing major surgery.
-	Investigate the subtypes of anaemia in those patients identified as being anaemic.
-	Identify differences in preoperative anaemia prevalence between different ethnic groups.
-	Identify differences in preoperative anaemia prevalence between surgical disciplines.
-	Describe the association between preoperative anaemia and transfusion of blood products.
-	Investigate the association between preoperative anaemia and patient morbidity and mortality.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Matthew Hart

Address

Starship Children's Hospital
2 Park Road,
Grafton,
Auckland 1023

Country

New Zealand

Phone

+64 9 367 0000

Fax

matthart@adhb.govt.nz

Contact person for public queries

Name

Caroline Mann

Address

Starship Children's Hospital
2 Park Road,
Grafton,
Auckland 1023

Country

New Zealand

Phone

+64 9 367 0000

Fax

carmann@adhb.govt.nz

Contact person for scientific queries

Name

Caroline Mann

Address

Starship Children's Hospital
2 Park Road,
Grafton,
Auckland 1023

Country

New Zealand

Phone

+64 9 367 0000

Fax

carmann@adhb.govt.nz

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?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17694	Study protocol			carmann@adhb.govt.nz

Results publications and other study-related documents

Documents added manually

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Documents added automatically

No additional documents have been identified.

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