ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Abdominal Surgery

Condition category

Condition code

Surgery

Other surgery

Blood

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]

Treatment: Drugs

Comparator / control treatment

No treatment

Control group

Active

Outcomes

Primary outcome [1]

Change in Haemoglobin (Hb) concentration on blood sample

Timepoint [1]

Baseline and 6 weeks from baseline

Primary outcome [2]

Recruitment rates per site. These will be assessed via audit of study recruitment records.

Timepoint [2]

At study completion

Secondary outcome [1]

Days Alive and Out of Hospital (DAOH). This will be assessed via patient medical records.

Timepoint [1]

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?

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment hospital [3]

The Northern Hospital - Epping

Recruitment hospital [4]

Broadmeadows Health Service - Broadmeadows

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3081 - Heidelberg West

Recruitment postcode(s) [3]

3076 - Epping

Recruitment postcode(s) [4]

3047 - Broadmeadows

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

CSL Vifor

Address [1]

Level 9 140 William Street Melbourne, VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 2, Education Building, Fiona Stanley Hospital 14 Barry Marshall Parade 
Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2023

Approval date [1]

Ethics approval number [1]

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

Mr Michael Issa

Address

University Hospital Geelong Bellerine Street, Geelong VIC 3220

Country

Australia

Phone

+61407477220

Fax

[email protected]

Contact person for public queries

Name

Michael Issa

Address

University Hospital Geelong Bellerine Street, Geelong VIC 3220

Country

Australia

Phone

+61407477220

Fax

[email protected]

Contact person for scientific queries

Name

Michael Issa

Address

University Hospital Geelong Bellerine Street, Geelong VIC 3220

Country

Australia

Phone

+61407477220

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case-by-case basis

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data collected during the trial, after de-identification will be available upon request to the Principal Investigator.

What types of analyses could be done with individual participant data?

• For meta-analyses and case-by-case basis on request with data-sharing agreement.

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main trial findings, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Subject to approvals by Principal Investigator. Data requests can be emailed to [email protected]

Are there extra considerations when requesting access to individual participant 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