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Trial registered on ANZCTR
Registration number
ACTRN12623000669695p
Ethics application status
Not yet submitted
Date submitted
5/06/2023
Date registered
21/06/2023
Date last updated
21/06/2023
Date data sharing statement initially provided
21/06/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
POSTVenTT RCT - Post-operative variability in anaemia treatment: a pilot randomised controlled trial.
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Scientific title
A two-arm, parallel-group, open label, randomised controlled feasibility trial assessing the effect of intravenous iron versus no treatment on haemoglobin concentration in anaemic patients undergoing abdominal surgery.
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Secondary ID [1]
309827
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None
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Universal Trial Number (UTN)
U1111-1293-3620
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Trial acronym
POSTVenTT
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Linked study record
ACTRN12622001447741
This record is a sub-study of ACTRN12622001447741
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Health condition
Health condition(s) or problem(s) studied:
Anaemia
330244
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Abdominal Surgery
330245
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Condition category
Condition code
Surgery
327113
327113
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0
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Other surgery
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Blood
327114
327114
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0
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Anaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active:
Intravenous iron infusion
Ferric carboxymaltose 1000 mg given intravenously
Intravenous iron will be administered once only postoperatively in accordance with local hospital guidelines. Adherence will be monitored in accordance with local hospital guidelines.
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Intervention code [1]
326261
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Treatment: Drugs
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Comparator / control treatment
No treatment
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in Haemoglobin (Hb) concentration on blood sample
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Assessment method [1]
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Timepoint [1]
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Baseline and 6 weeks from baseline
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Primary outcome [2]
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Recruitment rates per site. These will be assessed via audit of study recruitment records.
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Assessment method [2]
334988
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Timepoint [2]
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At study completion
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Secondary outcome [1]
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Days Alive and Out of Hospital (DAOH). This will be assessed via patient medical records.
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Assessment method [1]
422651
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Timepoint [1]
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6 weeks from recruitment
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Eligibility
Key inclusion criteria
Patients who meet the following criteria:
1. Adult (greater than or equal to 18 years of age)
2. Patients who have undergone major abdominal surgery during the study recruitment periods
3. Anaemia (Hb <130g/L in males, and <120g/L in females) demonstrated on blood tests performed either during or after the procedure
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who, at the start of treatment, meet any of the following criteria are not eligible for the study:
1. Erythropoietin or IV iron in the previous 4 weeks
2. Known hypersensitivity to iron or its excipients
3. Known chronic liver disease
4. Known family history of haemochromatosis or Transferrin Saturation (TSATS) >50%
5. Pregnancy or lactation
6. Unable to provide written informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be performed using a computer-generated code, access via a web-based service.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/09/2023
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Actual
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Date of last participant enrolment
Anticipated
27/10/2023
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Actual
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Date of last data collection
Anticipated
15/12/2023
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
24869
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [2]
24870
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Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment hospital [3]
24871
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The Northern Hospital - Epping
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Recruitment hospital [4]
24872
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Broadmeadows Health Service - Broadmeadows
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Recruitment postcode(s) [1]
40517
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3084 - Heidelberg
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Recruitment postcode(s) [2]
40518
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3081 - Heidelberg West
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Recruitment postcode(s) [3]
40519
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3076 - Epping
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Recruitment postcode(s) [4]
40520
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3047 - Broadmeadows
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Funding & Sponsors
Funding source category [1]
314024
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Commercial sector/Industry
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Name [1]
314024
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CSL Vifor
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Address [1]
314024
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Level 9 140 William Street Melbourne, VIC 3000
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Country [1]
314024
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
VERITAS Collaborative
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Address
Department of Surgery
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084
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Country
Australia
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Secondary sponsor category [1]
315993
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None
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Name [1]
315993
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Address [1]
315993
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Country [1]
315993
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
313159
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Level 2, Education Building, Fiona Stanley Hospital 14 Barry Marshall Parade
Murdoch WA 6150
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Ethics committee country [1]
313159
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Australia
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Date submitted for ethics approval [1]
313159
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26/06/2023
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Approval date [1]
313159
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Ethics approval number [1]
313159
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Summary
Brief summary
Anaemia affects nearly a quarter of the world, and is common in surgical patients with a third of patients presenting with preoperative anaemia and three quarters of patients discharged from hospital with anaemia. The World Health Organisation defines anaemia as an insufficient circulating red cell mass, with a haemoglobin (Hb) concentration of < 130 g.l-1 for men and < 120 g.l-1 for women.
Peri-operative anaemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogenic blood transfusions, which is an independent risk for poorer patient outcomes.
The most common cause of preoperative anaemia is iron deficiency, which can be caused by reduced or impaired dietary iron absorption, chronic blood loss, or disruption of normal iron metabolism due to co-morbidities or inflammation, aetiologies commonly seen in patients undergoing major abdominal surgery, which causes an increase in hepcidin production resulting in functional iron deficiency, and reduced red cell production. Surgical anaemia can be due to chronic disease, blood loss at operation or secondary to surgical inflammation. Cytokines (particularly IL-6) upregulate hepcidin, the master regulator of iron homeostasis, which prevents iron transport leading to failure of dietary iron absorption, and sequestration of iron within macrophages. This leads to functional iron deficiency and subsequently anaemia of chronic disease.
The efficacy of intravenous iron therapy may be impacted by the balance between the inflammatory modulation of iron sequestration and bone marrow suppression with the hypoxic drive for erythrogenesis. Although efficacy of intravenous iron was shown in the IRONMAN trial - performed in patients following ICU admission - and the PREVENTT trial in preoperative patients, the one size all approach may not be precise. Consequently, in the surgical pathway, the optimal timing and modality is unknown.
The outcome of this research will provide evidence on the efficacy of post-operative iron administration to treat anaemia in surgical patients. The study will also provide feasibility data to help support a larger future trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Michael Issa
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Address
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University Hospital Geelong
Bellerine Street, Geelong
VIC 3220
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Country
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Australia
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Phone
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+61407477220
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Michael Issa
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Address
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University Hospital Geelong
Bellerine Street, Geelong
VIC 3220
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Country
127163
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Australia
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Phone
127163
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+61407477220
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Fax
127163
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Email
127163
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[email protected]
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Contact person for scientific queries
Name
127164
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Mr Michael Issa
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Address
127164
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University Hospital Geelong
Bellerine Street, Geelong
VIC 3220
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Country
127164
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Australia
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Phone
127164
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+61407477220
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Fax
127164
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Email
127164
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data collected during the trial, after de-identification will be available upon request to the Principal Investigator.
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When will data be available (start and end dates)?
After publication of main trial findings, no end date
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Available to whom?
Case-by-case basis
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Available for what types of analyses?
For meta-analyses and case-by-case basis on request with data-sharing agreement.
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How or where can data be obtained?
Subject to approvals by Principal Investigator. Data requests can be emailed to
[email protected]
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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.
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