Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000133639
Ethics application status
Approved
Date submitted
21/07/2005
Date registered
12/08/2005
Date last updated
12/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of heparin on lung function following cardiopulmonary bypass.
Scientific title
The effect of heparin on alveolar dead space following cardiopulmonary bypass.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung injury following cardiac surgery. 221 0
Condition category
Condition code
Injuries and Accidents 249 249 0 0
Other injuries and accidents
Surgery 250 250 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double blind randomised trial comparing intravenous heparin versus placebo (5% glucose). The infusion will be commenced 8 - 10 hours prior to commencement of surgery and ceased prior to the insertion of lines or sternotomy.
Intervention code [1] 44 0
Prevention
Comparator / control treatment
Placebo (5% glucose)
Control group
Placebo

Outcomes
Primary outcome [1] 294 0
Alveolar dead space
Timepoint [1] 294 0
Over the first 4 hours following cardiopulmonary bypass.
Secondary outcome [1] 659 0
Plasma levels of prothrombin fragments, t.PA, D. dimer
Timepoint [1] 659 0
Over the first 4 hours following cardiopulmonary bypass.

Eligibility
Key inclusion criteria
Adult patients undergong elective cardiac surgery for coronary artery bypass grafting with cardiopulmonary bypass.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous adverse reaction to heparin. Active bleeding. An additional surgical procedure to coronary artery bypass grafting planned. Creatinine >200umol/L.

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)
The study drug is prepared by an independent nurse in our unit. This person is not involved in the conduct, administration or data collection for the study. The infusion bag is labelled 'study drug' and the patient's study number but identifies that it may be either heparin or placebo (in accordance with our hospitals drug labelling policy). Participants are numbered sequentially and there is a central list to tell the nurse which number and associated infusion to prepare.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator or odd and even numbers in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/11/2004
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)

Funding & Sponsors
Funding source category [1] 307 0
Charities/Societies/Foundations
Name [1] 307 0
Intensive Care Foundation and St Vincent's Hospital Melbourne ICU Research Fund
Country [1] 307 0
Australia
Primary sponsor type
Name
Nil
Address
Country
Secondary sponsor category [1] 239 0
None
Name [1] 239 0
Nil
Address [1] 239 0
Country [1] 239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1179 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 1179 0
Ethics committee country [1] 1179 0
Australia
Date submitted for ethics approval [1] 1179 0
Approval date [1] 1179 0
Ethics approval number [1] 1179 0

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

Contacts
Principal investigator
Name 36318 0
Address 36318 0
Country 36318 0
Phone 36318 0
Fax 36318 0
Email 36318 0
Contact person for public queries
Name 9233 0
Dr Barry Dixon
Address 9233 0
Intensive Care Unit
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 9233 0
Australia
Phone 9233 0
+61 3 9288 488
Fax 9233 0
+61 3 92884487
Email 9233 0
[email protected]
Contact person for scientific queries
Name 161 0
Dr Barry Dixon
Address 161 0
Intensive Care Unit
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 161 0
Australia
Phone 161 0
+61 3 92884488
Fax 161 0
+61 3 92884487
Email 161 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.