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Bleeding and clotting complications in patients having liver surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000802707
Acronym
CLOTS
Enrollment
52
Registered
2013-07-19
Start date
2013-08-14
Completion date
2015-06-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, can

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.

Sponsors

Dr Megan L Allen
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Adult patients undergoing hepatic resection for malignancy

Exclusion criteria

Refusal Clinical indication for anticoagulation perioperatively (except aspirin)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026