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Trial registered on ANZCTR


Registration number
ACTRN12613000738729
Ethics application status
Approved
Date submitted
22/04/2013
Date registered
3/07/2013
Date last updated
3/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nebulised Heparin for Heart Surgery
Scientific title
Nebulised Heparin for Heart Surgery: A Randomised, Double-Blind, Placebo-Controlled Trial to evaluate the effect of nebulised heparin on PaO2/FiO2 in patients undergoing coronary artery bypass grafting (CABG)
Secondary ID [1] 282376 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung injury following cardiac surgery 288958 0
Condition category
Condition code
Respiratory 289292 289292 0 0
Other respiratory disorders / diseases
Surgery 289304 289304 0 0
Other surgery
Inflammatory and Immune System 289305 289305 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a single dose of nebulised heparin (50,000 IU in 10 ml) or placebo (0.9% sodium chloride 10 ml) will be administered following anaesthetic induction.
Intervention code [1] 287009 0
Prevention
Intervention code [2] 287019 0
Treatment: Drugs
Comparator / control treatment
placebo nebulised (0.9% sodium chloride 10 ml)

Control group
Placebo

Outcomes
Primary outcome [1] 289402 0
Change in the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) over the operative period, assessed by analysis of arterial blood gas levels.
Timepoint [1] 289402 0
at end of surgery
Secondary outcome [1] 302403 0
duration of mechanical ventilation
Timepoint [1] 302403 0
measured while managed in ICU
Secondary outcome [2] 302404 0
Number and days of organ supports (mechanical ventilation, inotropes and haemofiltation) required over first 7 post-operative days.
Timepoint [2] 302404 0
over first 7 post-operative days.
Secondary outcome [3] 302405 0
mortality
Timepoint [3] 302405 0
hospital discharge

Eligibility
Key inclusion criteria
coronary artery bypass grafting (CABG) with 4 or more grafts
or a combined procedure of CABG with open aortic valve replacement.
Minimum age
18 Years
Maximum age
79 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to heparin; any history of heparin induced thrombocytopenia
Renal impairment (defined as creatinine >130 umol/L)
Planned to receive pre-operative heparin
Receiving systemic immunosuppressant (such as steroids, cyclosporine, azathioprine)
Marked limitation of physical activity: defined as development of fatigue or shortness of breath on walking 100 meters.

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)
allocation concealment will be undertaken. Allocation involved contacting the holder of the allocation schedule who was “off-site.”
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
nil
Phase
Phase 1
Type of endpoint(s)
Efficacy
Statistical methods / analysis
mixed model of primary end-point.

Based on the results on a study we undertook of the anti-inflammatory agent Etanercept on patients undergoing elective cardiac surgery we expect the fall in the PaO2/FiO2 over the operative period in the nebulised heparin arm to be 110 lower than that of the placebo arm. The SD is expected to be 100. Based on these assumptions, for the study to have a power of 0.9 and alpha of 0.05, a total of 37 patients are required. We have rounded this up to 40 patients.

Recruitment
Recruitment status
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)
VIC
Recruitment hospital [1] 935 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 6782 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 287147 0
Hospital
Name [1] 287147 0
St.Vincent's Hospital Departmental funds
Address [1] 287147 0
St.Vincents Hospital 41 Victoria Pde Fitzroy Victoria, 3065
Country [1] 287147 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Bellerine St Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 285914 0
None
Name [1] 285914 0
Address [1] 285914 0
Country [1] 285914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289145 0
Barwon Health
Ethics committee address [1] 289145 0
Bellerine St Geelong VIC 3220
Ethics committee country [1] 289145 0
Australia
Date submitted for ethics approval [1] 289145 0
16/04/2013
Approval date [1] 289145 0
Ethics approval number [1] 289145 0

Summary
Brief summary
Hypothesis and Outcomes: This study will test the primary hypothesis that nebulised heparin improves lung function, assessed by the change in the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) over the operative period. Secondary outcomes include the extent of post-operative organ supports and duration of intensive care and hospital stays.
Significance: Nebulised heparin offers the possibility of a cost-effective strategy to prevent respiratory failure developing in patients following heart surgery. Health benefits and healthcare cost savings could be substantial. An effective strategy could save the Australian healthcare system at least $8.5 million per year in intensive care costs alone.
Trial website
nil
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 39474 0
Dr Barry Dixon
Address 39474 0
ST. Vincents Hospital 41 Victoria Parade, Fitzroy VIC 3065
Country 39474 0
Australia
Phone 39474 0
+ 61 3 92884488
Fax 39474 0
+ 61 3 92884487
Email 39474 0
barry.dixon@svhm.org.au
Contact person for public queries
Name 39475 0
Dr Barry Dixon
Address 39475 0
ST. Vincents Hospital 41 Victoria Parade, Fitzroy VIC 3065
Country 39475 0
Australia
Phone 39475 0
+ 61 3 92884488
Fax 39475 0
+ 61 3 92884487
Email 39475 0
barry.dixon@svhm.org.au
Contact person for scientific queries
Name 39476 0
Dr Barry Dixon
Address 39476 0
ST. Vincents Hospital 41 Victoria Parade, Fitzroy VIC 3065
Country 39476 0
Australia
Phone 39476 0
+ 61 3 92884488
Fax 39476 0
+ 61 3 92884487
Email 39476 0
barry.dixon@svhm.org.au

No information has been provided regarding IPD availability
Summary results
No Results