ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001046291

Ethics application status

Approved

Date submitted

10/06/2018

Date registered

22/06/2018

Date last updated

27/06/2023

Date data sharing statement initially provided

27/06/2023

Date results provided

27/06/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

An observational study of perioperative anaemia and transfusion in surgical patients at St George Hospital.

Scientific title

An observational study of perioperative anaemia and transfusion in surgical patients at St George Hospital.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anaemia

iron deficiency

Condition category

Condition code

Blood

Anaemia

Metabolic and Endocrine

Other metabolic disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

We will be investigating the presence of anaemia in surgical patients, within 2 months prior to surgery up to the date of their surgery. Anaemia will be defined by a Hb less than 120g/L in females and less than 130g/L in males.

We will also be investigating the prevalance of iron deficient anaemia, within 2 months prior to surgery. Iron deficiency anaemia will be defined as anaemia with ferritin level less than 30mcg/L, or ferritin level less than 100mcg/L and Transferrin Saturation (TSats) less than 16%, we will be investigating the presence of anaemia in surgical patients within 2 months of their surgery.

We will also be investigating the prevalance of anaemia of chronic disease, within 2 months prior to surgery. Anaemia of chronic disease is defined as anaemia with ferritin greater than 100mcg/L and TSats greater than 16%

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Prevalence of anaemia (%) on patients hospital electronic blood test records

Timepoint [1]

2 months prior to surgery up to the date of their surgery

Secondary outcome [1]

Prevalence of haematinic studies in patients with pre-operative anaemia (measured in %) on patients hospital electronic blood test records

Timepoint [1]

2 months prior to surgery up to the date of their surgery

Secondary outcome [2]

Use of blood products peri-operatively at St George Hospital (measured by numbers of blood products transfused per surgical admission recorded on patients hospital electronic transfusion record

Timepoint [2]

during surgical admission (varaible depending on procedure)

Secondary outcome [3]

Use of packed red cells peri-operatively at St George Hospital (measured by numbers of packed red cells transfused per surgical admission recorded on patients hospital electronic transfusion record

Timepoint [3]

during surgical admission (varaible depending on procedure)

Secondary outcome [4]

Timing of first packed red cell transfusion as recorded on patients hospital electronic transfusion record

Timepoint [4]

measured in days from procedure

Secondary outcome [5]

Proportion of patients in whom preoperative blood testing is not recorded (measured in %) on patients hospital electronic blood test records

Timepoint [5]

2 months prior to surgery up to the date of their surgery

Eligibility

Key inclusion criteria

All surgical procedures performed at St George Hospital during 2017 in patients 16 years or older.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

All those undergoing a surgical procedure at St George Hospital under the age of 16 years.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Convenience sample

Timing

Retrospective

Statistical methods / analysis

Descriptive statistics will be used to describe the dataset, normally distributed outcomes reported as mean plus or minus standard deviations and non-normal data as median and interquartile range (IQR). Categorical data will be reported as counts and proportions. Missing data will be examined and reported as such. No hypothesis tests are planned at this stage.

Patients that have had multiple procedures will have each procedure treated independently.

The following results will be extracted:
% prevalence of anaemia
% prevalence of transfusion
% prevalence of Iron studies in anaemic patients

The following subgroup analysis are planned.
Prevalence of anaemia by:
specialty,
procedural consultant,
endoscopy/operation,
elective/emergency,
age and gender,
ASA status,
booking to procedure interval and
procedure name.

Prevalence of transfusion of any blood product by:
specialty,
procedural consultant,
endoscopy/operation,
elective/emergency,
age and gender,
ASA status,
booking to procedure interval and
procedure name.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2018

Actual

1/08/2018

Date of last participant enrolment

Anticipated

2/07/2018

Actual

1/08/2018

Date of last data collection

Anticipated

2/07/2018

Actual

1/08/2018

Sample size

Target

11000

Accrual to date

Final

7879

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St George Hospital - Kogarah

Recruitment postcode(s) [1]

2217 - Kogarah

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia, St George Hospital

Country [1]

Australia

Primary sponsor type

Hospital

Name

Department of Anaesthesia, St George Hospital

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District HREC

Ethics committee address [1]

G71 East Wing 
Edmund Blacket Building
Prince of Wales Hospital
Avoca Street
Randwick
NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/05/2018

Approval date [1]

26/06/2018

Ethics approval number [1]

2018/ETH00187

Summary

Brief summary

Pre-operative anaemia, as defined by the World Health Organisation criteria, has a prevalence in non-cardiac surgery of around 25% and is associated with poorer outcomes peri-operatively.  It also increases the chance of transfusion and increases risk of death in cardiac surgery.  

Blood transfusion is often used to correct peri-operative anaemia and whilst life saving in acute major haemorrhage is a limited resource and, is itself associated with morbidity and mortality.  It remains unclear if treating anaemia in the peri-operative period can positively influence morbidity or mortality.  However benefit from patient blood management interventions, including pre-operative anaemia optimisation, has been shown to reduce the need for blood transfusion with possible trends towards improved patient outcomes.  

Guidelines have been published recommending identification and active management of preoperative anaemia.   An excellent goal directed review has been undertaken by the Australian National Blood Authority and also supports identification and optimisation of pre-operative anaemia.

A preliminary look reviewing colorectal patients over a six month period in 2017 was recently undertaken at St George.  Of the 171 elective operative cases found, ninety had a preoperative haemoglobin reported thirty of which were anaemic (33% of those who had a haemoglobin).  Eight patients were transfused during the peri-operative period, the majority of whom were anaemic before surgery.  This pilot study supports the published literature, and implies the problem of pre-operative anaemia is present at St George and currently insufficiently managed.

Pre-operative anaemia may be an optimisable risk factor for our patients at St. George, first however we need to understand which patient groups are at greatest risk, their current management (blood product transfusions) and then how and where to focus our efforts.  This work has not been previously undertaken at St George.

The primary aim of the proposed study is to document the prevalence of anaemia pre-operatively and transfusion practice for all patients having a procedure in 2017 at St George Hospital.  

Secondary aims include the documentation of anaemia according to surgical speciality, of pre-operative iron deficiency anaemia, anaemia of chronic disease and of blood product transfusions according to patient demographics and surgical speciality.  The study will also examine the timings from booking to surgery and pre-operative assessment to surgery to consider how best to optimise Haemoglobin (Hb) during the patients pre-operative pathway.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Ilana Delroy Buelles

Address

Dept of Anaesthesia Gray St St George Hospital Kogarah NSW 2217

Country

Australia

Phone

+61 2 9113 1111

Fax

ilanadb@doctors.org.uk

Contact person for public queries

Name

Matthew Miller

Address

Dept of Anaesthesia Gray St St George Hospital Kogarah NSW 2217

Country

Australia

Phone

+61 2 9113 1111

Fax

matthew.miller1@health.nsw.gov.au

Contact person for scientific queries

Name

Matthew Miller

Address

Dept of Anaesthesia Gray St St George Hospital Kogarah NSW 2217

Country

Australia

Phone

+61 2 9113 1111

Fax

matthew.miller1@health.nsw.gov.au

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: not ethically approved to share data

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.

Trial Review

Documents added manually

Documents added automatically