Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001623381
Ethics application status
Approved
Date submitted
29/11/2017
Date registered
13/12/2017
Date last updated
12/03/2018
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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
Intraoperative.
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.

Eligibility
Key inclusion criteria
Colonic cancer secondary to the liver or cholangiocarcinoma requiring liver resection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA repeated measures

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
Date of last participant enrolment
Anticipated
28/10/2019
Actual
Date of last data collection
Anticipated
6/11/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
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
Charities/Societies/Foundations
Name [1] 298101 0
Medical Research Foundation of Royal Perth Hospital
Country [1] 298101 0
Australia
Primary sponsor type
Individual
Name
Kwok Ming Ho
Address
ICU, Royal Perth Hospital, Wellington Street, Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 297178 0
None
Name [1] 297178 0
Address [1] 297178 0
Country [1] 297178 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 299121 0
29/11/2017
Approval date [1] 299121 0
09/03/2018
Ethics approval number [1] 299121 0

Summary
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

Contacts
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
Australia
Phone 79366 0
+61 8 92241056
Fax 79366 0
+61 8 92243668
Email 79366 0
[email protected]
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
Australia
Phone 79367 0
+ 61 8 92241056
Fax 79367 0
+61 8 92243668
Email 79367 0
[email protected]
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
Australia
Phone 79368 0
+61 8 92241056
Fax 79368 0
+ 61 8 92243668
Email 79368 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
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