Trial Review

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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 information initially 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] 295158 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaemia 308270 0
iron deficiency 308271 0
Condition category
Condition code
Blood 307283 307283 0 0
Anaemia
Metabolic and Endocrine 307367 307367 0 0
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] 301497 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306240 0
Prevalence of anaemia (%) on patients hospital electronic blood test records
Timepoint [1] 306240 0
2 months prior to surgery up to the date of their surgery
Secondary outcome [1] 347942 0
Prevalence of haematinic studies in patients with pre-operative anaemia (measured in %) on patients hospital electronic blood test records
Timepoint [1] 347942 0
2 months prior to surgery up to the date of their surgery
Secondary outcome [2] 347946 0
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] 347946 0
during surgical admission (varaible depending on procedure)
Secondary outcome [3] 347947 0
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] 347947 0
during surgical admission (varaible depending on procedure)
Secondary outcome [4] 347948 0
Timing of first packed red cell transfusion as recorded on patients hospital electronic transfusion record
Timepoint [4] 347948 0
measured in days from procedure
Secondary outcome [5] 347951 0
Proportion of patients in whom preoperative blood testing is not recorded (measured in %) on patients hospital electronic blood test records
Timepoint [5] 347951 0
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?
No
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] 11119 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 22932 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 299748 0
Hospital
Name [1] 299748 0
Department of Anaesthesia, St George Hospital
Country [1] 299748 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St George Hospital
Address
Gray St
Kogarah
Sydney
NSW 2217
Country
Australia
Secondary sponsor category [1] 299086 0
None
Name [1] 299086 0
Address [1] 299086 0
Country [1] 299086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300638 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 300638 0
G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Avoca Street
Randwick
NSW 2031
Ethics committee country [1] 300638 0
Australia
Date submitted for ethics approval [1] 300638 0
22/05/2018
Approval date [1] 300638 0
26/06/2018
Ethics approval number [1] 300638 0
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84298 0
Dr Ilana Delroy Buelles
Address 84298 0
Dept of Anaesthesia
Gray St
St George Hospital
Kogarah
NSW 2217
Country 84298 0
Australia
Phone 84298 0
+61 2 9113 1111
Fax 84298 0
Email 84298 0
[email protected]
Contact person for public queries
Name 84299 0
Dr Matthew Miller
Address 84299 0
Dept of Anaesthesia
Gray St
St George Hospital
Kogarah
NSW 2217
Country 84299 0
Australia
Phone 84299 0
+61 2 9113 1111
Fax 84299 0
Email 84299 0
[email protected]
Contact person for scientific queries
Name 84300 0
Dr Matthew Miller
Address 84300 0
Dept of Anaesthesia
Gray St
St George Hospital
Kogarah
NSW 2217
Country 84300 0
Australia
Phone 84300 0
+61 2 9113 1111
Fax 84300 0
Email 84300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo 10.31219/osf.io/8udmr
Plain language summaryNo Anemic patients are at increased risk of intraoper... [More Details]

Documents added automatically
No additional documents have been identified.