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Trial registered on ANZCTR


Registration number
ACTRN12612000336886
Ethics application status
Approved
Date submitted
15/02/2012
Date registered
23/03/2012
Date last updated
23/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Isofurans Production under Hyperbaric conditions: an observational study in patients with osteonecrosis secondary to radiotherapy
Scientific title
Serum Isofurans trend levels in patients with osteonecrosis undergoing hyperbaric therapy
Secondary ID [1] 273370 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 279151 0
Examination of Isofurans 285920 0
Osteonecrosis 285921 0
Hyperbaric therapy 285922 0
Condition category
Condition code
Inflammatory and Immune System 279340 279340 0 0
Normal development and function of the immune system
Musculoskeletal 286112 286112 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measuring Isofurans compound levels in serum during hyperbaric treatment. We will be taking 7 blood samples (through one peripheral cannula) during the first hyperbaric treatment of a patient with radio-osteonecrosis. The serum levels of Isofurans (and other routine bloods such as a full blood picture / urea and electrolytes) will be recorded. The duration of this study is expected to be 12 months from beginning of data collection (i.e. finish date by June 2013)
Intervention code [1] 283710 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279941 0
To measure serum IsoFs levels at different stages during hyperbaric therapy and observe the resultant trend
Timepoint [1] 279941 0
Weekly for a total of 12 months
Secondary outcome [1] 294816 0
Nil
Timepoint [1] 294816 0
Nil

Eligibility
Key inclusion criteria
1. Patients currently booked for hyperbaric therapy to treat osteonecrosis secondary to radiation therapy
2. 18 years and over
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active systemic infection / inflammatory disease
2. Any risk factors for barotrauma
3. Current steroid use

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284719 0
Hospital
Name [1] 284719 0
Fremantle Hospital
Address [1] 284719 0
1/3 Alma Street Fremantle Western Australia 6160
Country [1] 284719 0
Australia
Primary sponsor type
Individual
Name
Dr. Tomas Corcoran
Address
Royal Perth Hospital
Anaesthetics Department
GPO Box X2213
Perth, WA 6001
Country
Australia
Secondary sponsor category [1] 269148 0
Individual
Name [1] 269148 0
Dr. Ed O'Loughlin
Address [1] 269148 0
Fremantle Hospital
Anaesthetics Department
Alma Street
Perth, WA 6160
Country [1] 269148 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286157 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 286157 0
PO Box 480 FREMANTLE WA 6959
Ethics committee country [1] 286157 0
Australia
Date submitted for ethics approval [1] 286157 0
01/12/2011
Approval date [1] 286157 0
20/12/2011
Ethics approval number [1] 286157 0
1/11/0359

Summary
Brief summary
‘Isofurans’ are a group of compounds that are produced by the body when it is exposed to high levels of oxygen. It is a relatively new discovery (2002) and reflects the amount of stress to the body caused by exposure to oxygen. There is still a good deal we do not know about this subject, however it could be linked to a number of illnesses, including Parkinson’s and certain types of lung and eye injuries. We aim to study the production of Isofurans under high oxygen pressures (hyperbaric), which has not been done before. The study will involve taking blood samples from patients who require hyperbaric treatment to improve bone production after radiotherapy, and monitoring the effect this has on Isofurans levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33382 0
Address 33382 0
Country 33382 0
Phone 33382 0
Fax 33382 0
Email 33382 0
Contact person for public queries
Name 16629 0
Sonya Ting
Address 16629 0
Fremantle Hospital
1/3 Alma Street Fremantle Western Australia 6160
Country 16629 0
Australia
Phone 16629 0
+61 8 9431 3333
Fax 16629 0
Email 16629 0
sonyating@gmail.com
Contact person for scientific queries
Name 7557 0
Ed O'Loughlin
Address 7557 0
Fremantle Hospital
1/3 Alma Street
Fremantle WA 6160
Country 7557 0
Australia
Phone 7557 0
+61 8 9431 3333
Fax 7557 0
Email 7557 0
edmond.o'loughlin@heath.wa.gov.au

No data has been provided for results reporting
Summary results
Not applicable