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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of taking an oral anti-oxidant supplement on blood clot formation before and after liver surgery
Scientific title
Effects of Resveratrol on Coagulation in Patients Undergoing Liver Resection for Cancers: a phase II double-blind randomised-controlled trial
Secondary ID [1] 293482 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver cancer 305673 0
Condition category
Condition code
Surgery 304893 304893 0 0
Other surgery
Cancer 305003 305003 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Blood 305004 305004 0 0
Clotting disorders

Study type
Description of intervention(s) / exposure
Oral resveratrol (1g/day) or placebo capsules for 7 days before liver resection for cancer. Study drug compliance will be confirmed with the patients on the day of surgery.
Intervention code [1] 299725 0
Treatment: Other
Intervention code [2] 299802 0
Treatment: Drugs
Comparator / control treatment
Indistinguishable placebo capsule (containing fine sugar ~1g).
Control group

Primary outcome [1] 304085 0
Maximum Clot Firmness (MCF) on the ROTEM blood test
Timepoint [1] 304085 0
7 day after study intervention (both immediately before surgery after induction of anaesthesia and immediately after surgery on admission to the intensive care unit).
All MCF results at three study time points (pre-intervention, 7 days after taking resveratrol and immediately after surgery) will be used in the Repeated Measures of ANOVA analysis to generate one p value when comparing the treatment and placebo group.
Secondary outcome [1] 340906 0
Blood loss intraoperative in ml according to surgeon and anaesthetist's estimation.
Timepoint [1] 340906 0
Secondary outcome [2] 341133 0
Blood product transfusion requirements
Timepoint [2] 341133 0
Intraoperatively and within 24 hrs after surgery, using patient medical records confirmed by blood bank transfusion records.

Key inclusion criteria
Colonic cancer secondary to the liver or cholangiocarcinoma requiring liver resection.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients with known coagulation abnormality, treated with systemic anticoagulants, taking resveratrol as part of their usual supplements before enrolment, and pregnant patients.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequential numbered sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis
ANOVA repeated measures

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9463 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 18189 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 298101 0
Name [1] 298101 0
Medical Research Foundation of Royal Perth Hospital
Address [1] 298101 0
MRF, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country [1] 298101 0
Primary sponsor type
Kwok Ming Ho
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Secondary sponsor category [1] 297178 0
Name [1] 297178 0
Address [1] 297178 0
Country [1] 297178 0

Ethics approval
Ethics application status
Ethics committee name [1] 299121 0
East Metropolitan Health Service Ethics Committee
Ethics committee address [1] 299121 0
Royal Perth Hospital, Wellington Street, Perth, WA 6000
Ethics committee country [1] 299121 0
Date submitted for ethics approval [1] 299121 0
Approval date [1] 299121 0
Ethics approval number [1] 299121 0

Brief summary
This study will determine the effect of resveratrol - a plant derived polyphenol - on blood clot formation in patients undergoing liver resection for cancers

Who is it for?
You may be eligible to join this study if you are aged 18 years old or above and have colonic cancer secondary to the liver or cholangiocarcinoma requiring liver resection

Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive resveratrol capsules (2 capsules with a total of resveratrol 1g/day) in the morning daily for 7 days before surgery, whilst participants in the other group will receive a placebo (2 capsules of fine sugar ~1g/day) in the morning daily for 7 days before surgery.

Blood taken from participants before and after surgery will be used to analyse blood clot formation in participants.

The proposed study is an essential step before a larger confirmatory phase II clinical study including important patient-centred outcomes can be initiated. A larger phase II study will provide the much needed information about the benefits and harms of using resveratrol in major cancer surgery.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 79366 0
A/Prof Kwok Ming Ho
Address 79366 0
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country 79366 0
Phone 79366 0
+61 8 92241056
Fax 79366 0
+61 8 92243668
Email 79366 0
Contact person for public queries
Name 79367 0
A/Prof Kwok Ming Ho
Address 79367 0
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country 79367 0
Phone 79367 0
+ 61 8 92241056
Fax 79367 0
+61 8 92243668
Email 79367 0
Contact person for scientific queries
Name 79368 0
A/Prof Kwok Ming Ho
Address 79368 0
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country 79368 0
Phone 79368 0
+61 8 92241056
Fax 79368 0
+ 61 8 92243668
Email 79368 0

No data has been provided for results reporting
Summary results
Not applicable