Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000785707
Ethics application status
Approved
Date submitted
13/04/2013
Date registered
15/07/2013
Date last updated
15/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The indications, logistical factors, benefits and adverse effects of the use of iron transfusion during surgery for surgical patients with iron deficiency anaemia.
Scientific title
An observational study into the use of iron transfusion intraoperatively for surgical patients with iron deficiency anaemia at Fremantle Hospital over a three month period.
Secondary ID [1] 282331 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anaemia in the perioperative period 288878 0
Condition category
Condition code
Blood 289219 289219 0 0
Anaemia
Anaesthesiology 289220 289220 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will investigate the use of iron transfusion intraoperatively in patients who are known to have iron deficiency anaemia, or become anaemic due to blood loss during surgery. The dose of iron is calculated based on patient age, gender, weight and haemoglobin level and is administered as a one off infusion in theatre. This is an observational study looking at indications, patterns of use and any adverse effects noted while administering an iron transfusion intraoperatively. The study will take place over a three month period, from the end of July to the end of October 2013.
Intervention code [1] 286946 0
Not applicable
Comparator / control treatment
Not applicable- observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289333 0
Number of intraoperative iron transfusions. This will be assessed by the anaesthetist administering the transfusion completing a data collection form during the surgical procedure, outlining patient demographics, type, dose and duration of iron transfusion and other data including the indications, adverse effects noted and logistical factors contributing to the decision to give iron.
Timepoint [1] 289333 0
Three month period from end of July to the end of October. Data sheets will be completed by the anaesthetist as the iron transfusions are administered and collected on a daily basis. The results will be reviewed on a weekly basis throughout the three month period, and finally analysed at the end of the three month period.
Primary outcome [2] 289334 0
Number of adverse outcomes secondary to an intraoperative iron transfusion. Adverse effects may include skin itching and urticaria, bronchospasm, back pain, nausea, indigestion, abdominal pain, headache, hypotension, tachycardia, joint or muscle pain, syncope and circulatory collapse. These adverse effects are listed on the data collection form. The anaesthetist administering the transfusion will assess whether any adverse effects occur related to the iron infusion and will then record this on a data collection form.
Timepoint [2] 289334 0
Three month period from end of July to the end of October. Data sheets will be completed by the anaesthetist as the iron transfusions are administered and collected on a daily basis. The results will be reviewed on a weekly basis throughout the three month period, and finally analysed at the end of the three month period.
Secondary outcome [1] 302256 0
Number of patients requiring blood transfusion after intraoperative iron infusion. Once the data collection forms are submitted, the principal investigator will access a hospital patient information system and which will document whether any units of blood product were administered to the patient after the surgery. This information will be recorded on the data collection form.
Timepoint [1] 302256 0
The study will be undertaken over a three month period from the end of July to the end of October. This outcome will be assessed at the end of the three month period, once all data forms have been submitted.

Eligibility
Key inclusion criteria
Surgical patients with known iron deficiency anaemia preoperatively.
Surgical patients with significant blood loss intraoperatively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known severe adverse reaction to iron transfusion.
Known iron storage disorder eg haemochromatosis.
Emergency situation in theatre which precludes the ability to give iron transfusion

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
N/A

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2013
Actual
Date of last participant enrolment
Anticipated
30/10/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 891 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 6691 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 287088 0
Hospital
Name [1] 287088 0
Fremantle Hospital
Country [1] 287088 0
Australia
Primary sponsor type
Individual
Name
Dr Bojana Stepanovic
Address
Fremantle Hospital
2 Alma Street Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 285864 0
None
Name [1] 285864 0
Address [1] 285864 0
Country [1] 285864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289103 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 289103 0
2 Alma Street Fremantle
WA 6160
Ethics committee country [1] 289103 0
Australia
Date submitted for ethics approval [1] 289103 0
16/04/2013
Approval date [1] 289103 0
12/06/2013
Ethics approval number [1] 289103 0

Summary
Brief summary
This project is a prospective observational study, which aims to investigate the use of intraoperative iron infusion, initiated by anaesthetists, during surgical procedures at Fremantle Hospital over a three month period. The use of intraoperative iron transfusions is highly variable among anaesthetists, and the study aims to investigate the logistical and other practical reasons for this. It will identify the indications for intra-operative iron transfusion and note any adverse effects in the perioperative period. A secondary aim is to investigate postoperative haemoglobin values and need for transfusion postoperatively in patients who have received an intraoperative iron transfusion. Iron infusions have been shown to be a valuable therapy for anaemia, and this study investigates the effectiveness, safety and efficiency of providing that therapy intraoperatively.
Trial website
Trial related presentations / publications
Public notes
Review Article: http://www.ncbi.nlm.nih.gov/pubmed/21239816

Contacts
Principal investigator
Name 39262 0
Dr Bojana Stepanovic
Address 39262 0
Fremantle Hospital
2 Alma St Fremantle, WA 6160
Country 39262 0
Australia
Phone 39262 0
+61 8 9431 3333
Fax 39262 0
Email 39262 0
bojana.stepanovic@health.wa.gov.au
Contact person for public queries
Name 39263 0
Dr Bojana Stepanovic
Address 39263 0
Fremantle Hospital
2 Alma St Fremantle, WA 6160
Country 39263 0
Australia
Phone 39263 0
+61 8 9431 3333
Fax 39263 0
Email 39263 0
bojana.stepanovic@health.wa.gov.au
Contact person for scientific queries
Name 39264 0
Dr Bojana Stepanovic
Address 39264 0
Fremantle Hospital
2 Alma St Fremantle, WA 6160
Country 39264 0
Australia
Phone 39264 0
+61 8 9431 3333
Fax 39264 0
Email 39264 0
bojana.stepanovic@health.wa.gov.au

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

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