Trial Review

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
ACTRN12611000387921
Ethics application status
Approved
Date submitted
7/04/2011
Date registered
13/04/2011
Date last updated
12/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of intravenous iron for patients with anaemia around the time of surgery
Scientific title
The role of intravenous iron compared to standard treatment for patients booked for major abdominal surgery with anaemia around the time of surgery in reduction in allogeneic red cell transfusion".
Secondary ID [1] 259953 0
nil
Universal Trial Number (UTN)
U1111-1120-6310
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 265581 0
Blood 265590 0
Condition category
Condition code
Anaesthesiology 265726 265726 0 0
Anaesthetics
Surgery 265727 265727 0 0
Other surgery
Blood 265779 265779 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomized to the intervention group will be exposed to intravenenous admistration of Ferric carboxymaltose before (1000mg or max 15mg /kg) and after surgery (50mg per 100ml estimated blood loss)
Intervention code [1] 264365 0
Treatment: Drugs
Comparator / control treatment
the control group will be managed according to current common practice at the discretion of the surgeon. current practice is correction of moderate to severe anaemia by red cell transfusion and/or on occasion oral iron.
Control group
Active

Outcomes
Primary outcome [1] 266484 0
allogeneic transfusion rate, during hospital stay, pre- and post op, according to medical records
Timepoint [1] 266484 0
at the time of discharge from the hospital, medical records
Secondary outcome [1] 273870 0
length of stay according to medical records
Timepoint [1] 273870 0
at the time of discharge from the hospital
Secondary outcome [2] 273871 0
Quality of life, questionnaire SF 36
Timepoint [2] 273871 0
at 4 weeks post discharge, questionnaire, documentation at surgeon follow up

Eligibility
Key inclusion criteria
Anaemia
Hb, Ferritin <300 micro g/L
female<120 gram/L, Transferrin Sat <25%
male<130 gram/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other causes of anaemia – haemaglobinopahty, GI bleeding, acute systemic infection, vitamin B12 or folate deficiency, hepatitis, HIV
No consent
Severe asthma
Allergy to iron
Pre-treatment ferritin levels > 300 ng/ml

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)
anaemic patients for major abdominal surgery 4-21 days prior to surgery.
Computer random number generator to give you the random sequence and then put this sequence in consecutively numbered opaque sealed envelopes to ensure allocation concelament.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator to give you the random sequence and then put this sequence in consecutively numbered opaque sealed envelopes to ensure allocation concelament.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2011
Actual
27/08/2011
Date of last participant enrolment
Anticipated
Actual
23/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
136
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264838 0
Self funded/Unfunded
Name [1] 264838 0
Country [1] 264838 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Hospital
Address
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 263940 0
None
Name [1] 263940 0
none
Address [1] 263940 0
none
Country [1] 263940 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266802 0
ETHICS OF HUMAN RESEARCH COMMITTEE (TQEH & LMH)
Ethics committee address [1] 266802 0
Executive Officer, Human Research Ethics Committee

The Queen Elizabeth Hospital, Lyell McEwin Hospital & Modbury Hospital
Adelaide Health Service

Ground Floor, Basil Hetzel Institute for Medical Research, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
Ethics committee country [1] 266802 0
Australia
Date submitted for ethics approval [1] 266802 0
Approval date [1] 266802 0
13/07/2010
Ethics approval number [1] 266802 0
2009108

Summary
Brief summary
investigators decided to decline the sponsorship offer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32456 0
Dr Bernd Froessler
Address 32456 0
Dept of Anaesthesia Lyell McEwin Hospital Haydown Rd Elizabeth Vale SA 5112
Country 32456 0
Australia
Phone 32456 0
+61881829806
Fax 32456 0
Email 32456 0
[email protected]
Contact person for public queries
Name 15703 0
Dr Dr Bernd Froessler
Address 15703 0
Dept of Anaesthesia
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 15703 0
Australia
Phone 15703 0
+61881829806
Fax 15703 0
Email 15703 0
[email protected]
Contact person for scientific queries
Name 6631 0
Dr Dr Bernd Froessler
Address 6631 0
Dept of Anaesthesia
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 6631 0
Australia
Phone 6631 0
+61881829806
Fax 6631 0
Email 6631 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseAssessing the costs and benefits of perioperative iron deficiency anemia management with ferric carboxymaltose in Germany.2018https://dx.doi.org/10.2147/RMHP.S157379
EmbaseThe important role for intravenous iron in perioperative patient blood management in major abdominal surgery.2016https://dx.doi.org/10.1097/SLA.0000000000001646
N.B. These documents automatically identified may not have been verified by the study sponsor.