Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001517864
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
8/11/2021
Date last updated
8/11/2021
Date data sharing statement initially provided
8/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
POST-operative Variations in anaemia treatmenT and Transfusions (POSTVenTT)
Scientific title
POST-operative Variations in anaemia treatmenT and Transfusions (POSTVenTT): a prospective, multicentre, observational cohort study of anaemia after major abdominal surgery
Secondary ID [1] 304150 0
None
Universal Trial Number (UTN)
Trial acronym
POSTVenTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative anaemia following major abdominal surgery 321845 0
Condition category
Condition code
Blood 319571 319571 0 0
Anaemia
Surgery 319643 319643 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An audit of the compliance to pre-, intra-, and postoperative guidelines for the management of anaemia in patients undergoing major abdominal surgery. The audit aims to follow up with patients at around 30 days to assess their outcomes.
Intervention code [1] 320485 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327430 0
Adherence to selected National Blood Authority (NBA) and International consensus statement guidelines for anaemia management. The outcome will be assessed by a review of medical records.
Timepoint [1] 327430 0
The adherence to NBA and International consensus statement guidelines for anaemia management will be assessed for the entire length of hospital stay and 30 days follow up.
Secondary outcome [1] 395112 0
Postoperative anaemia measured by Hemoglobin. Anaemia is defined as Haemoglobin < 120g/L in women and <130g/L in men.
Timepoint [1] 395112 0
Following discharge from post-operative anaesthetic recovery area, a high-dependency unit (HDU) or intensive care unit (ICU) and at day 3 and day 7.
Secondary outcome [2] 395113 0
Postoperative blood transfusion. The number of post-operative blood infusions will be assessed by a review of medical records.
Timepoint [2] 395113 0
After surgery till discharge
Secondary outcome [3] 395114 0
Haemoglobin (Hb) level. The Hb level will be assessed using blood samples.
Timepoint [3] 395114 0
At discharge from the hospital
Secondary outcome [4] 395115 0
Postoperative complications as defined by Clavien-Dindo classification
Timepoint [4] 395115 0
At 30-days
Secondary outcome [5] 395117 0
Length of in-patient hospital stay via review of medical records
Timepoint [5] 395117 0
Day(s)
Secondary outcome [6] 395120 0
Patient frailty as defined by the Clinical Frailty Scale
Timepoint [6] 395120 0
Pre-operatively (before surgery) and at 30 days follow up.
Secondary outcome [7] 395121 0
Re-operations. This may involved surgery at the same site, at another site for the same condition, or to repair a feature from previous surgery. Reoperations will be assessed by a review of medical records.
Timepoint [7] 395121 0
Post-operatively for the length of the hospital stay.
Secondary outcome [8] 395122 0
Readmissions following discharge after admission for index operation via review of medical records
Timepoint [8] 395122 0
At or before 30 days

Eligibility
Key inclusion criteria
Consecutive adult patients undergoing major emergency or elective abdominal surgery will be eligible for inclusion.

Age: Adult patients, 18 years or above

Procedure: Major abdominal surgery, defined as an operation with an incision into the abdominal cavity and anticipated duration of more than one hour. Procedures performed using any surgical approach, including open, laparoscopic, and robotic surgery are included.

Urgency: Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Procedures: Abdominal surgery classified as minor operations such as; laparoscopic appendicectomy (emergency or elective), endoscopic procedures, transanal or transurethral procedures. A complete list can be found in the appendix 1.

Indication: Palliative procedures as determined pre-operatively and explicitly stated in the medical record or consent form.

Extent of surgery: Operations that are either:

Staged with a planned return for reoperation (such as but not limited to damage control laparotomy or burns surgery)

Change in operative plan such that during the first procedure it is determined that a reoperation is necessary, even if the patient was enrolled pre-operatively

Return to theatre: Patients returning to theatre due to complications following earlier surgery can be included, as long as their index procedure has not already been included in the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on preliminary study registration interest, study recruitment is anticipated to be conducted in 13 centres in New Zealand and 46 centres in Australia. Additional centres are expected from the United Kingdom and Europe. Australia and New Zealand contributed 4500 patients to COVIDSurg-Week study which included all operations over a possible four 1-week periods (COVIDSurg Collaborative and GlobalSur...). Assuming 25% of these surgeries are major abdominal surgeries, we anticipate an estimated sample-size of over 1100 participants which is in-line with previous collaborative studies cov

Adherence to perioperative anaemia management guidelines will be collected for the cohort. Confounding factors for risk of anaemia will be adjusted to generate accurate risk adjustment models for outcomes, particularly the use of intravenous iron and blood transfusion.
Statistical analysis will involve independent samples t-tests for normally distributed variables; Mann-Whitney U-tests for non-normal or ordinal factors; and chi-square or Fisher’s exact test for categorical variables. A multivariable analysis will then be performed using binary logistic regression to identify significant independent predictors of postoperative anaemia. Subsequent multivariable binary logistic regression models will be created to assess if postoperative anaemia is an independent predictor of postoperative complications, length of stay, and hospital readmissions.

Subgroup analyses will be performed to determine differences between emergency and elective groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
12/11/2021
Actual
Date of last data collection
Anticipated
19/11/2021
Actual
Sample size
Target
2000
Accrual to date
2730
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 19297 0
Westmead Hospital - Westmead
Recruitment hospital [2] 19298 0
Gosford Hospital - Gosford
Recruitment hospital [3] 19299 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 19300 0
Canterbury Hospital - Campsie
Recruitment hospital [5] 19301 0
John Hunter Hospital - New Lambton
Recruitment hospital [6] 19302 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 19303 0
The Maitland Hospital - Maitland
Recruitment hospital [8] 19304 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [9] 19305 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 19306 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 19307 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [12] 19308 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [13] 19309 0
Mount Gambier and Districts Health Service - Mount Gambier
Recruitment hospital [14] 19310 0
Port Lincoln Health Services - Port Lincoln
Recruitment hospital [15] 19311 0
Whyalla Hospital - Whyalla
Recruitment hospital [16] 19312 0
Port Augusta Hospital - Port Augusta
Recruitment hospital [17] 19313 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [18] 19314 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [19] 19315 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [20] 19316 0
Logan Hospital - Meadowbrook
Recruitment hospital [21] 19317 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [22] 19318 0
The Townsville Hospital - Douglas
Recruitment hospital [23] 19319 0
Cairns Base Hospital - Cairns
Recruitment hospital [24] 19320 0
The Northern Hospital - Epping
Recruitment hospital [25] 19321 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [26] 19322 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [27] 19323 0
Western Hospital - Footscray - Footscray
Recruitment hospital [28] 19324 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [29] 19325 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [30] 19326 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [31] 19327 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [32] 19328 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [33] 19329 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [34] 19330 0
Bairnsdale Regional Health Service - Bairnsdale
Recruitment hospital [35] 19331 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [36] 19332 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [37] 19333 0
Royal Perth Hospital - Perth
Recruitment hospital [38] 19334 0
Bunbury Hospital - Bunbury
Recruitment hospital [39] 19335 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [40] 19336 0
Launceston General Hospital - Launceston
Recruitment hospital [41] 19337 0
North West Regional Hospital - Burnie
Recruitment hospital [42] 19338 0
Royal Hobart Hospital - Hobart
Recruitment hospital [43] 19339 0
The Canberra Hospital - Garran
Recruitment hospital [44] 19340 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [45] 19341 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 33880 0
2145 - Westmead
Recruitment postcode(s) [2] 33881 0
2250 - Gosford
Recruitment postcode(s) [3] 33882 0
2139 - Concord
Recruitment postcode(s) [4] 33883 0
2194 - Campsie
Recruitment postcode(s) [5] 33884 0
2305 - New Lambton
Recruitment postcode(s) [6] 33885 0
2298 - Waratah
Recruitment postcode(s) [7] 33886 0
2320 - Maitland
Recruitment postcode(s) [8] 33887 0
2200 - Bankstown
Recruitment postcode(s) [9] 33888 0
5000 - Adelaide
Recruitment postcode(s) [10] 33889 0
5042 - Bedford Park
Recruitment postcode(s) [11] 33890 0
5112 - Elizabeth Vale
Recruitment postcode(s) [12] 33891 0
5011 - Woodville
Recruitment postcode(s) [13] 33892 0
5290 - Mount Gambier
Recruitment postcode(s) [14] 33893 0
5606 - Port Lincoln
Recruitment postcode(s) [15] 33894 0
5600 - Whyalla
Recruitment postcode(s) [16] 33895 0
5700 - Port Augusta
Recruitment postcode(s) [17] 33896 0
4350 - Toowoomba
Recruitment postcode(s) [18] 33897 0
4575 - Birtinya
Recruitment postcode(s) [19] 33898 0
4102 - Woolloongabba
Recruitment postcode(s) [20] 33899 0
4131 - Meadowbrook
Recruitment postcode(s) [21] 33900 0
4108 - Coopers Plains
Recruitment postcode(s) [22] 33901 0
4814 - Douglas
Recruitment postcode(s) [23] 33902 0
4870 - Cairns
Recruitment postcode(s) [24] 33903 0
3076 - Epping
Recruitment postcode(s) [25] 33904 0
3084 - Heidelberg
Recruitment postcode(s) [26] 33905 0
3128 - Box Hill
Recruitment postcode(s) [27] 33906 0
3011 - Footscray
Recruitment postcode(s) [28] 33907 0
3550 - Bendigo
Recruitment postcode(s) [29] 33908 0
3220 - Geelong
Recruitment postcode(s) [30] 33909 0
3052 - Parkville
Recruitment postcode(s) [31] 33910 0
2050 - Camperdown
Recruitment postcode(s) [32] 33911 0
3065 - Fitzroy
Recruitment postcode(s) [33] 33912 0
2640 - Albury
Recruitment postcode(s) [34] 33913 0
3875 - Bairnsdale
Recruitment postcode(s) [35] 33914 0
6150 - Murdoch
Recruitment postcode(s) [36] 33915 0
6009 - Nedlands
Recruitment postcode(s) [37] 33916 0
6000 - Perth
Recruitment postcode(s) [38] 33917 0
6230 - Bunbury
Recruitment postcode(s) [39] 33918 0
6112 - Armadale
Recruitment postcode(s) [40] 33919 0
7250 - Launceston
Recruitment postcode(s) [41] 33920 0
7320 - Burnie
Recruitment postcode(s) [42] 33921 0
7000 - Hobart
Recruitment postcode(s) [43] 33922 0
2605 - Garran
Recruitment postcode(s) [44] 33923 0
2617 - Bruce
Recruitment postcode(s) [45] 33924 0
3168 - Clayton
Recruitment outside Australia
Country [1] 23675 0
New Zealand
State/province [1] 23675 0
Country [2] 23676 0
Spain
State/province [2] 23676 0

Funding & Sponsors
Funding source category [1] 308594 0
University
Name [1] 308594 0
The University of Western Australia
Country [1] 308594 0
Australia
Funding source category [2] 308987 0
Other Collaborative groups
Name [2] 308987 0
Royal Australasian College of Surgeons (RACS) Clinical Trials Network Australia and New Zealand (CTANZ)
Country [2] 308987 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service (SMHS)
Address
Fiona Stanley Hospital.
11 Robin Warren Drive, MURDOCH WESTERN AUSTRALIA 6150
Country
Australia
Secondary sponsor category [1] 309380 0
University
Name [1] 309380 0
The University of Western Australia
Address [1] 309380 0
35 Stirling Highway, CRAWLEY WESTERN AUSTRALIA 6009
Country [1] 309380 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308480 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 308480 0
Ethics committee country [1] 308480 0
Australia
Date submitted for ethics approval [1] 308480 0
Approval date [1] 308480 0
21/01/2021
Ethics approval number [1] 308480 0
PRN: RGS0000004477

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

Contacts
Principal investigator
Name 110842 0
Prof Toby Richards
Address 110842 0
The University of Western Australia Medical School, Division of Surgery (M581)
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital Campus
5 Robin Warren Drive, MURDOCH WA 6150
Country 110842 0
Australia
Phone 110842 0
+61 8 6151 1178
Fax 110842 0
Email 110842 0
[email protected]
Contact person for public queries
Name 110843 0
Giuliana D’aulerio
Address 110843 0
The University of Western Australia Medical School, Division of Surgery (M581)
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital Campus
5 Robin Warren Drive, MURDOCH WA 6150
Country 110843 0
Australia
Phone 110843 0
+61 8 6151 1067
Fax 110843 0
Email 110843 0
[email protected]
Contact person for scientific queries
Name 110844 0
Toby Richards
Address 110844 0
The University of Western Australia Medical School, Division of Surgery (M581)
Harry Perkins Institute of Medical Research, Fiona Stanley Hospital Campus
5 Robin Warren Drive, MURDOCH WA 6150
Country 110844 0
Australia
Phone 110844 0
+61 8 6151 1178
Fax 110844 0
Email 110844 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 as per protocol and approved ethics


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11597Study protocol    381946-(Uploaded-13-05-2021-19-29-53)-Study-related document.pdf
11598Ethical approval    381946-(Uploaded-13-05-2021-19-30-11)-Study-related document.pdf



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.