Trial Review

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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
ACTRN12608000001392
Ethics application status
Not yet submitted
Date submitted
21/12/2007
Date registered
7/01/2008
Date last updated
30/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigations into a TNF inhibitor to limit complications following complex surgery
Scientific title
Investigations into a TNF inhibitor to limit complications following complex surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular surgery 2656 0
Condition category
Condition code
Surgery 2774 2774 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A intravenous (IV) TNF inhibitor.
A single 100 ml dose of TNF inhibitor administered IV over 30 minutes, just prior to surgery. The control treatment is standard care. The follow up period will be 90 days.
Intervention code [1] 2398 0
Treatment: Drugs
Comparator / control treatment
The control group will receive standard treatment. That is care routinely given to patients undergoing vascular surgery. No placebo will be given. The follow up period will be 90 days.
Control group
Active

Outcomes
Primary outcome [1] 3662 0
TNF levels in blood tests
Timepoint [1] 3662 0
Blood tests will be taken at 1,2 and 4 hours following anaesthetic induction
Secondary outcome [1] 6186 0
Adverse events
Timepoint [1] 6186 0
Total number of adverse events will be reviewed at 90 days

Eligibility
Key inclusion criteria
Scheduled for elective vascular surgery
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
concurrent use of Interleukin-1 antagonist, septic arthritis in last 12 months, any infection, pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients on elective waiting list will be approached. Consent obtained. Randomized using random number computer sequence. No concealment of patients or treating doctors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 523 0
3065

Funding & Sponsors
Funding source category [1] 2913 0
Government body
Name [1] 2913 0
National heart foundation
Country [1] 2913 0
Australia
Primary sponsor type
Hospital
Name
St.Vincent's Health Melbourne
Address
41 Victoria Pde,
Fitzroy, 3065
Melbourne
1
Country
Australia
Secondary sponsor category [1] 2632 0
None
Name [1] 2632 0
Address [1] 2632 0
Country [1] 2632 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4853 0
St Vincent's Health Melbourne
Ethics committee address [1] 4853 0
41 Victoria Pde,
Fitzroy, 3065
Melbourne
Ethics committee country [1] 4853 0
Australia
Date submitted for ethics approval [1] 4853 0
14/12/2007
Approval date [1] 4853 0
Ethics approval number [1] 4853 0
HREC-D 146/07

Summary
Brief summary
This trial will assess if a TNF inhibitor is safe to administer to patients undergoing vascular surgery. If so we will commence further trials to assess if a TNF inhibitor improves clinical outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28260 0
Address 28260 0
Country 28260 0
Phone 28260 0
Fax 28260 0
Email 28260 0
Contact person for public queries
Name 11417 0
Barry Dixon
Address 11417 0
St.Vincent's Health,
41 Victoria Pde,
Fitzroy, 3065
Melbourne
Country 11417 0
Australia
Phone 11417 0
0392884488
Fax 11417 0
Email 11417 0
barry.dixon@svhm.org.au
Contact person for scientific queries
Name 2345 0
Barry Dixon
Address 2345 0
St.Vincent's Health
41 Victoria Pde,
Fitzroy, 3065
Country 2345 0
Australia
Phone 2345 0
0392884488
Fax 2345 0
Email 2345 0
barry.dixon@svhm.org.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.