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
ACTRN12608000121369
Ethics application status
Not yet submitted
Date submitted
27/12/2007
Date registered
5/03/2008
Date last updated
5/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of inhaled heparin in patients with acute lung injury
Scientific title
A phase 2 randomised blinded trial of nebulised heparin in patients requiring mechanical ventilation for more than 48 hours
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lung injury 2659 0
Condition category
Condition code
Infection 2779 2779 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inhaled heparin (5 ml) will be given daily for 14 days or until extubation
Intervention code [1] 2401 0
Treatment: Drugs
Comparator / control treatment
Nebulised normal saline 5ml will be given daily for 14 days or until extubation
Control group
Placebo

Outcomes
Primary outcome [1] 3665 0
Arterial to inspired oxygen ratio will be measured by assessing the oxygen level in a arterial blood sample
Timepoint [1] 3665 0
Daily for up to 14 days
Secondary outcome [1] 6189 0
Adverse events
Timepoint [1] 6189 0
Daily for up to 14 days

Eligibility
Key inclusion criteria
Has or at high risk of developing acute lung injury
Minimum age
15 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
At risk of pulmonary hemorrhage
Allergy to heparin

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 524 0
3065
Recruitment postcode(s) [2] 789 0
3065

Funding & Sponsors
Funding source category [1] 2918 0
Other
Name [1] 2918 0
Intensive Care Foundation
Country [1] 2918 0
Australia
Primary sponsor type
Hospital
Name
St.Vincent's Health
Address
41 Victoria Pde
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 2635 0
None
Name [1] 2635 0
Address [1] 2635 0
Country [1] 2635 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4860 0
St.Vincent's Hospital, Melbourne
Ethics committee address [1] 4860 0
Ethics committee country [1] 4860 0
Australia
Date submitted for ethics approval [1] 4860 0
02/02/2008
Approval date [1] 4860 0
Ethics approval number [1] 4860 0
Ethics committee name [2] 5129 0
Ethics committee address [2] 5129 0
Ethics committee country [2] 5129 0
Date submitted for ethics approval [2] 5129 0
02/02/2008
Approval date [2] 5129 0
Ethics approval number [2] 5129 0
008/08

Summary
Brief summary
To investigate if nebulised heparin improves oxygenation of patients with acute lung injury
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28263 0
Address 28263 0
Country 28263 0
Phone 28263 0
Fax 28263 0
Email 28263 0
Contact person for public queries
Name 11420 0
Barry Dixon
Address 11420 0
St. Vincent's Health
41 Victoria Pde
Fitzroy Melbourne VIC 3065
Country 11420 0
Australia
Phone 11420 0
+61 3 92884488
Fax 11420 0
Email 11420 0
[email protected]
Contact person for scientific queries
Name 2348 0
Barry Dixon
Address 2348 0
St. Vincent's Health
41 Victoria Pde
Fitzroy Melbourne VIC 3065
Country 2348 0
Australia
Phone 2348 0
+61 3 92884488
Fax 2348 0
Email 2348 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
No additional documents have been identified.