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Trial registered on ANZCTR


Registration number
ACTRN12624000410550p
Ethics application status
Submitted, not yet approved
Date submitted
4/03/2024
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Post Operative Iron Infusion for the Treatment of Anaemia in Trauma Patients
Scientific title
A Pilot Study of Post Operative Iron Infusion for the Treatment of Anaemia in Trauma Patients
Secondary ID [1] 311663 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 333120 0
Trauma 333121 0
Condition category
Condition code
Blood 329811 329811 0 0
Anaemia
Emergency medicine 329989 329989 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 Arm study, Phase IV trial
1 arm will receive study drug, other arm will receive placebo. Both will be blinded by blacked out tubing and syringes

1 arm of the recruited trauma patients that are anaemic post-operatively will be given a single dose of ferric carboxymaltose 1,000 mg intravenous iron in 250mL of saline (up to a maximum of 20 mg iron/kg body weight). All patients will be given the maximum single dose of 1000mg unless their weight is <50Kg in which case the calculation will be applied to determine dose (20 mg iron/kg body weight). Infusion will be given once over 15 minutes by a member of the treating team at the Alfred Hospital so the study team remain blinded.

The treatment will be administered on the ward prior to patients' discharge. The exact timing that each patient will the receive the treatment will vary, but it will be in the days following surgery while they are recovering on the ward.
Intervention code [1] 328124 0
Treatment: Drugs
Comparator / control treatment
Intravenous 250mL normal (0.9%) saline infusion given over 15 minutes
Control group
Placebo

Outcomes
Primary outcome [1] 337585 0
Consent rate
Timepoint [1] 337585 0
At conclusion of recruitment
Primary outcome [2] 337586 0
Successful study drug administration
Timepoint [2] 337586 0
At time of infusion for each patient
Primary outcome [3] 337587 0
Follow up attendance rate
Timepoint [3] 337587 0
At day 30 post infusion for each patient
Secondary outcome [1] 432409 0
Hb level
Timepoint [1] 432409 0
Day 30 post infusion follow up for each patient
Secondary outcome [2] 432410 0
Days alive and out of hospital
Timepoint [2] 432410 0
Day 30 post infusion follow up for each patient
Secondary outcome [3] 433562 0
Disability
Timepoint [3] 433562 0
Participants will complete baseline prior to infusion and at 30 day follow-up
Secondary outcome [4] 433563 0
Fatigue
Timepoint [4] 433563 0
Participants will complete baseline prior to infusion and at 30 day follow-up
Secondary outcome [5] 433564 0
Quality of Recovery
Timepoint [5] 433564 0
Participants will complete at 30 day follow-up

Eligibility
Key inclusion criteria
Patients over the age of 18 admitted to the Alfred for treatment of trauma with post-operative anaemia at the time of enrolment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient refusal
• Iron transfusion prior to admission, surgery or intraoperatively
• Hb <80 – these patients will be referred for treatment and transfusion
• Patients with pre-existing haematological disorders or any condition associated with iron overload
• Traumatic brain injury, neurological deficit or cognitive impairment that would impact compliance with surveys and follow up investigations
• Patients with known hypersensitivity to IV iron

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)
Participants that are eligible will be assigned randomly from a computer-generated list to either IV iron or placebo in a 1:1 ratio. Randomisation will be conducted by trained research staff in the online research electronic data capture (REDCap Consortium)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants that are eligible will be assigned randomly from a computer-generated list to either IV iron or placebo in a 1:1 ratio. Randomisation will be conducted by trained research staff in the online research electronic data capture (REDCap Consortium)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26236 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 42204 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 315991 0
Hospital
Name [1] 315991 0
Alfred Health - Department of Anaesthesiology and Perioperative Medicine
Country [1] 315991 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health - Department of Anaesthesiology and Perioperative Medicine
Address
Country
Australia
Secondary sponsor category [1] 318139 0
None
Name [1] 318139 0
Address [1] 318139 0
Country [1] 318139 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314816 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314816 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314816 0
Australia
Date submitted for ethics approval [1] 314816 0
06/03/2024
Approval date [1] 314816 0
Ethics approval number [1] 314816 0

Summary
Brief summary
• We are studying patients with anaemia who have had trauma surgery.
• Anaemia is a deficiency in the number or quality of red blood cells.
• Red blood cells carry oxygen around the body, using a protein called haemoglobin.
• Anaemia exists when either the level of red blood cells or haemoglobin is lower than normal.
• A treatment, involving a single intravenous (IV) injection of iron medication in hospital prior to discharge, is expected to improve the body’s ability to better correct anaemia.
• This could result in a faster recovery, but we don’t not know if the IV iron injection truly works in people following trauma – this is why we are doing this trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132818 0
Dr Mark Shulman
Address 132818 0
Department of Anaesthesiology and Perioperative Medicine, The Alfred, 55 Commercial Road, Melbourne, 3004, Victoria
Country 132818 0
Australia
Phone 132818 0
+61 0390763176
Fax 132818 0
Email 132818 0
m.shulman@alfred.org.au
Contact person for public queries
Name 132819 0
Sophie Wallace
Address 132819 0
Department of Anaesthesiology and Perioperative Medicine, The Alfred, 55 Commercial Road, Melbourne, 3004, Victoria
Country 132819 0
Australia
Phone 132819 0
+61 0390762651
Fax 132819 0
Email 132819 0
s.wallace@alfred.org.au
Contact person for scientific queries
Name 132820 0
Sophie Wallace
Address 132820 0
Department of Anaesthesiology and Perioperative Medicine, The Alfred, 55 Commercial Road, Melbourne, 3004, Victoria
Country 132820 0
Australia
Phone 132820 0
+61 0390762651
Fax 132820 0
Email 132820 0
s.wallace@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.