Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000328572
Ethics application status
Approved
Date submitted
31/05/2006
Date registered
3/08/2006
Date last updated
3/08/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of heparin to prevent lung microvascular thrombosis in patients administered aprotinin undergoing cardiac surgery for ischemic heart disease
Scientific title
Use of heparin to prevent lung microvascular thrombosis in patients administered aprotinin undergoing cardiac surgery for ischemic heart disease for ischemic heart disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic heart disease 1297 0
Condition category
Condition code
Cardiovascular 1387 1387 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic heparin intravenous infusion (18U/kg/Hr) over the 3 hours prior to commencement of surgery.
Intervention code [1] 1080 0
Treatment: Drugs
Comparator / control treatment
Control group will receive an equivalent infusion of 5% dextrose with no active drug.
Control group
Placebo

Outcomes
Primary outcome [1] 1891 0
Evidence of microvascular thrombosis on lung biopsy
Timepoint [1] 1891 0
Taken at the end of cardiac surgery
Secondary outcome [1] 3344 0
Alveolar dead space
Timepoint [1] 3344 0
Meausured at induction and at the end of cardiac surgery.

Eligibility
Key inclusion criteria
Elective cardiac surgery.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Repeat cardiac surgery , complex surgery.

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)
yes, contacting the holder of the allocation schedule who is "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table generated by computer software into blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/08/2006
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] 1521 0
Hospital
Name [1] 1521 0
St Vincents Health Melbourne intensive care unit
Country [1] 1521 0
Australia
Primary sponsor type
Hospital
Name
St. Vincents Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1336 0
Hospital
Name [1] 1336 0
St. Vincents Hospital Melbourne
Address [1] 1336 0
Country [1] 1336 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2945 0
St Vincents Melbourne,
Ethics committee address [1] 2945 0
Ethics committee country [1] 2945 0
Australia
Date submitted for ethics approval [1] 2945 0
Approval date [1] 2945 0
27/07/2006
Ethics approval number [1] 2945 0
067/06

Summary
Brief summary
Patients undergoing cardiac surgery administered aprotinin will be enrolled. Patients will be randomised to receive a pre-operative heaprin infusion or placebo. A lung biopsy will be taken to determine if pre-operative heaprin prevents the development of microvascular thrombosis in the lungs.

Hypothesis. Heparin prevents the formation of blood clots in the lungs following cardiac surgery.

The patients enrolled, the therapists and the data collectors will all be blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36055 0
Address 36055 0
Country 36055 0
Phone 36055 0
Fax 36055 0
Email 36055 0
Contact person for public queries
Name 10269 0
Barry Dixon
Address 10269 0
St. Vincents Hospital
Victoria Parade
Fitzroy VIC 3065
Country 10269 0
Australia
Phone 10269 0
+61 3 92884488
Fax 10269 0
+61 3 92884487
Email 10269 0
[email protected]
Contact person for scientific queries
Name 1197 0
Barry Dixon
Address 1197 0
St. Vincents Hospital
Victoria Parade
Fitzroy VIC 3065
Country 1197 0
Australia
Phone 1197 0
+61 3 92884488
Fax 1197 0
+61 3 92884487
Email 1197 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.