Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000388516
Ethics application status
Approved
Date submitted
28/07/2006
Date registered
5/09/2006
Date last updated
5/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial to assess the safety of nebulised heparin for acute lung injury
Scientific title
A trial to assess the safety of nebulised heparin for acute lung injury
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute lung injury 1354 0
Condition category
Condition code
Respiratory 1445 1445 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nebulised Heparin 25,000 U bd in normal saline. Given 12 hourly for 2 days.
Intervention code [1] 1234 0
Treatment: Drugs
Comparator / control treatment
Control: normal saline. Given 12 hourly for 2 days.
Control group
Placebo

Outcomes
Primary outcome [1] 1993 0
Safety
Timepoint [1] 1993 0
All measured 1 hour after the nebulised drug is given.
Primary outcome [2] 1994 0
Bleeding
Timepoint [2] 1994 0
All measured 1 hour after the nebulised drug is given.
Primary outcome [3] 1995 0
Activated partial thromboplastin time
Timepoint [3] 1995 0
All measured 1 hour after the nebulised drug is given.
Secondary outcome [1] 3457 0
Alveolar dead space
Timepoint [1] 3457 0
Measured one hour after each episode of the nebulised drug.

Eligibility
Key inclusion criteria
Acute lung injurymechanical ventilation.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Systemic heparin administrationPulmonary haemorrhage.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1583 0
Charities/Societies/Foundations
Name [1] 1583 0
Intensive care foundation
Country [1] 1583 0
Primary sponsor type
Charities/Societies/Foundations
Name
St Vincents Health Melboune
Address
Country
Australia
Secondary sponsor category [1] 1390 0
None
Name [1] 1390 0
nil
Address [1] 1390 0
Country [1] 1390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3008 0
St Vincents Health Melbourne
Ethics committee address [1] 3008 0
Ethics committee country [1] 3008 0
Australia
Date submitted for ethics approval [1] 3008 0
Approval date [1] 3008 0
27/07/2006
Ethics approval number [1] 3008 0
088/060

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36090 0
Address 36090 0
Country 36090 0
Phone 36090 0
Fax 36090 0
Email 36090 0
Contact person for public queries
Name 10423 0
Barry Dixon
Address 10423 0
St Vincents Health
55 Victoria Pde
Fitzroy VIC 3065
Country 10423 0
Australia
Phone 10423 0
+61 3 92884488
Fax 10423 0
+61 3 92884487
Email 10423 0
[email protected]
Contact person for scientific queries
Name 1351 0
Barry Dixon
Address 1351 0
St Vincents Health
55 Victoria Pde
Fitzroy VIC 3065
Country 1351 0
Australia
Phone 1351 0
+61 3 92884488
Fax 1351 0
+61 3 92884487
Email 1351 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.