Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000802707
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
19/07/2013
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Date results information initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Bleeding and clotting complications in patients having liver surgery
Scientific title
An observational thromboelastography study to explore the impact of liver surgery on coagulation profile, bleeding events, thromboembolic events and endothelial function in patients undergoing hepatic resection at Peter MacCallum Cancer Centre
Secondary ID [1] 282832 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CLOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver resection 289616 0
Bleeding 289617 0
Thrombosis 289618 0
Endothelial Function 289619 0
Condition category
Condition code
Blood 289954 289954 0 0
Clotting disorders
Cancer 289975 289975 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of patients undergoing hepatic resection to characterise the changes to coagulation which are experienced and correlate these with patient, perioperative and surgical factors.
Patients will be observed from the day of surgery until 1 year post surgery with review points at: Day 1, Day 3, Day 5 (if certain conditions met), week 2-3 (clinic review time), week 4-6 (clinic review time) and 1 year (clinic review time).

At the 1 year review only survival status, cancer recurrence and reporting of any further bleeding or clotting events will be recorded. No blood tests or endothelial assessment will occur at 1 year.
Intervention code [1] 287523 0
Not applicable
Comparator / control treatment
Nil - prospective cohort study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290008 0
Identify predictive thrombogenic biomarkers, to assess changes throughout the perioperative period in patients undergoing hepatic resection.

Biomarkers will include: Coagulation profile (APTT, PT, INR, Fibrinogen, D-dimer), Thromboelastograph (TEG - Registered Trademark), vWF, FVIIIc, TM, TATC, PF1 + 2, Fibrin monomers

Detection of bleeding and clotting events will be by routine clinical investigations directed by the treating team (observation, ultrasonography, CT scanning etc)
Timepoint [1] 290008 0
Day of surgery to day 3 post surgery
Secondary outcome [1] 303764 0
Determine the temporal pattern of thromboembolism and bleeding events throughout the perioperative period for hepatic resection surgery

Detection of bleeding and clotting events will be by routine clinical investigations directed by the treating team if indicated (observation, ultrasonography, CT scanning etc)
Timepoint [1] 303764 0
Day of surgery until 6 weeks post surgery
Secondary outcome [2] 303765 0
Develop a thromboembolism risk-model from clinical and thrombogenic biomarkers, for prospective validation and incorporation into risk-targeted thromboprophylaxis guidelines appropriate for hepatic resection
Timepoint [2] 303765 0
Day of surgery until 6 weeks post surgery
Secondary outcome [3] 303766 0
Investigate endothelial function in patients undergoing hepatic resection for cancer

Assessment will involve the use of the EndoPAT non-invasive finger probe
Timepoint [3] 303766 0
Day of surgery until day 3 post surgery

Eligibility
Key inclusion criteria
Adult patients undergoing hepatic resection for malignancy
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal
Clinical indication for anticoagulation perioperatively (except aspirin)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The sample size is a pragmatic sample based on the caseload at Peter MacCallum Cancer Centre and the funding available for the thrombogenic biomarker assays and a reasonable belief that these results will be meaningful.

Descriptive statistics in addition to multivariable regression methods to explore the relationships between coagulation markers and clinical factors

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2013
Actual
14/08/2013
Date of last participant enrolment
Anticipated
Actual
24/06/2015
Date of last data collection
Anticipated
Actual
27/06/2016
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1280 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 287617 0
Charities/Societies/Foundations
Name [1] 287617 0
Feilman foundation
Country [1] 287617 0
Australia
Primary sponsor type
Individual
Name
Dr Megan L Allen
Address
Department of Anaesthesia
Peter MacCallum Cancer Centre
East Melbourne
Locked Bag 1, A'Beckett Street VIC Australia 8006
Country
Australia
Secondary sponsor category [1] 286361 0
None
Name [1] 286361 0
Address [1] 286361 0
Country [1] 286361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289588 0
Ethics Committee Secretariat
Ethics committee address [1] 289588 0
Peter MacCallum Cancer Centre
East Melbourne
Locked Bag 1, A'Beckett Street VIC Australia 8006
Ethics committee country [1] 289588 0
Australia
Date submitted for ethics approval [1] 289588 0
Approval date [1] 289588 0
11/07/2013
Ethics approval number [1] 289588 0
13_52L

Summary
Brief summary
This is an observational study evaluating bleeding and clotting complications in patients undergoing liver surgery for cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are undergoing hepatic resection (i.e. surgical removal of all or a portion of the liver) for malignancy at Peter MacCallum Cancer Centre. Study details Changes to the blood clotting system following liver surgery have not been well characterised and information is conflicting. The traditional view is that as the liver makes important clotting factors surgery would reduce this production and make patients more likely to bleed. However, some recent work has suggested that actually liver resection patients are prone to blood clotting and the bigger the surgery the higher the risk. This study aims to use laboratory tests of coagulation to determine what actually occurs. Patients will be observed from the day of surgery until 1 year post surgery with review points at: Day 1, Day 3, Day 5 (if certain conditions met), week 2-3 (clinic review time), week 4-6 (clinic review time) and 1 year (clinic review time). Data collected from this study will help us to develop guidelines for management of blood clotting around the time of liver surgery. Additionally, the rate of bleeding and clotting complications will also be recorded.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41438 0
Dr Megan Allen
Address 41438 0
Department of Anaesthesia
Peter MacCallum Cancer Centre
East Melbourne
Locked Bag 1, A'Beckett Street VIC Australia 8006
Country 41438 0
Australia
Phone 41438 0
+61 3 9656 1111
Fax 41438 0
Email 41438 0
megan.allen@petermac.org
Contact person for public queries
Name 41439 0
Dr Megan Allen
Address 41439 0
Department of Anaesthesia
Peter MacCallum Cancer Centre
East Melbourne
Locked Bag 1, A'Beckett Street VIC Australia 8006
Country 41439 0
Australia
Phone 41439 0
+61 3 9656 1111
Fax 41439 0
Email 41439 0
megan.allen@petermac.org
Contact person for scientific queries
Name 41440 0
Dr Megan Allen
Address 41440 0
Department of Anaesthesia
Peter MacCallum Cancer Centre
East Melbourne
Locked Bag 1, A'Beckett Street VIC Australia 8006
Country 41440 0
Australia
Phone 41440 0
+61 3 9656 1111
Fax 41440 0
Email 41440 0
megan.allen@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.