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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.
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.
Secondary ID [1] 309827 0
None
Universal Trial Number (UTN)
U1111-1293-3620
Trial acronym
POSTVenTT
Linked study record
ACTRN12622001447741

This record is a sub-study of ACTRN12622001447741

Health condition
Health condition(s) or problem(s) studied:
Anaemia 330244 0
Abdominal Surgery 330245 0
Condition category
Condition code
Surgery 327113 327113 0 0
Other surgery
Blood 327114 327114 0 0
Anaemia

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326261 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 334987 0
Change in Haemoglobin (Hb) concentration on blood sample
Timepoint [1] 334987 0
Baseline and 6 weeks from baseline
Primary outcome [2] 334988 0
Recruitment rates per site. These will be assessed via audit of study recruitment records.
Timepoint [2] 334988 0
At study completion
Secondary outcome [1] 422651 0
Days Alive and Out of Hospital (DAOH). This will be assessed via patient medical records.
Timepoint [1] 422651 0
6 weeks from recruitment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
Date of last participant enrolment
Anticipated
27/10/2023
Actual
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24869 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 24870 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [3] 24871 0
The Northern Hospital - Epping
Recruitment hospital [4] 24872 0
Broadmeadows Health Service - Broadmeadows
Recruitment postcode(s) [1] 40520 0
3047 - Broadmeadows
Recruitment postcode(s) [2] 40519 0
3076 - Epping
Recruitment postcode(s) [3] 40518 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 40517 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 314024 0
Commercial sector/Industry
Name [1] 314024 0
CSL Vifor
Country [1] 314024 0
Australia
Primary sponsor type
Other Collaborative groups
Name
VERITAS Collaborative
Address
Department of Surgery
Austin Hospital
145 Studley Road
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 315993 0
None
Name [1] 315993 0
Address [1] 315993 0
Country [1] 315993 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313159 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 313159 0
Level 2, Education Building, Fiona Stanley Hospital 14 Barry Marshall Parade
Murdoch WA 6150
Ethics committee country [1] 313159 0
Australia
Date submitted for ethics approval [1] 313159 0
26/06/2023
Approval date [1] 313159 0
Ethics approval number [1] 313159 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127162 0
Mr Michael Issa
Address 127162 0
University Hospital Geelong
Bellerine Street, Geelong
VIC 3220
Country 127162 0
Australia
Phone 127162 0
+61407477220
Fax 127162 0
Email 127162 0
michael.issa02@gmail.com
Contact person for public queries
Name 127163 0
Mr Michael Issa
Address 127163 0
University Hospital Geelong
Bellerine Street, Geelong
VIC 3220
Country 127163 0
Australia
Phone 127163 0
+61407477220
Fax 127163 0
Email 127163 0
michael.issa02@gmail.com
Contact person for scientific queries
Name 127164 0
Mr Michael Issa
Address 127164 0
University Hospital Geelong
Bellerine Street, Geelong
VIC 3220
Country 127164 0
Australia
Phone 127164 0
+61407477220
Fax 127164 0
Email 127164 0
michael.issa02@gmail.com

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 collected during the trial, after de-identification will be available upon request to the Principal Investigator.
When will data be available (start and end dates)?
After publication of main trial findings, no end date
Available to whom?
Case-by-case basis
Available for what types of analyses?
For meta-analyses and case-by-case basis on request with data-sharing agreement.
How or where can data be obtained?
Subject to approvals by Principal Investigator. Data requests can be emailed to Michael.issa02@gmail.com


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.