Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001078842
Ethics application status
Approved
Date submitted
30/08/2012
Date registered
9/10/2012
Date last updated
9/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence on blood clotting of the consumption of fish oils.
Scientific title
The Effects of therapeutic doses of Fish Oil on Coagulation Studies in healthy volunteers
Secondary ID [1] 281124 0
Nil
Universal Trial Number (UTN)
Trial acronym
EFOCS (Effects of Fish Oil On Coagulation Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potential Coagualopathy caused by fish oil 287293 0
Condition category
Condition code
Blood 287624 287624 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of two groups of healthy volunteers consuming either 3grams or 12grams per day of Fish Oil capsules.
Fish Oil is consumed for four weeks, and then discontinued for four weeks
Intervention code [1] 285582 0
Treatment: Drugs
Comparator / control treatment
Dose comparison of 3grams of fishoil against 12 grams of fish oil per day for four weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 287872 0
Caogualtion studies- Thromboelastography (TEG/ROTEM)
Timepoint [1] 287872 0
Samples at 0, 1 and 4 weeks of fishoil consumption and 1 and 4 weeks after cessation of fishoil
Secondary outcome [1] 298969 0
Platelet microparticle concentrations
Timepoint [1] 298969 0
Samples at 0, 1 and 4 weeks of fishoil consumption and 1 and 4 weeks after cessation of fishoil

Eligibility
Key inclusion criteria
ASA 1 or 2
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients taking any regular medication (exc oral contraceptive)
Confirmed coagulation disorder (pathological or drug induced)
BMI >35
Documented allergy to O3FA
Documented pregnancy

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)
Allocation not concealed to volunteer or enrolment team. Allocation concealed to laboratory staff analyzing blood.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285904 0
Hospital
Name [1] 285904 0
Royal Perth Hospital Medical Research Foundation
Country [1] 285904 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington Street Campus
Perth
Western Australia
6000
Country
Australia
Secondary sponsor category [1] 284726 0
None
Name [1] 284726 0
Address [1] 284726 0
Country [1] 284726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287931 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 287931 0
Wellington Street Campus
Perth
WA
6000
Ethics committee country [1] 287931 0
Australia
Date submitted for ethics approval [1] 287931 0
Approval date [1] 287931 0
28/02/2012
Ethics approval number [1] 287931 0
EC2011/143

Summary
Brief summary
There is strong evidence that the use of omega-3 fatty acids (O3FAs) reduces cardiovascular
risk in certain populations. Major bodies such as the Australian National Heart Foundation
(NHF), American Heart Association (AHA) and British Heart Foundation (BHF) have
recommended their use which has lead to widespread uptake by the general population. As their
use becomes more prevalent, increasing numbers of patients are presenting for surgery whilst
taking O3FAs.
Amongst the potential adverse effects of O3FAs, there is theoretical suspicion that these
compounds may reduce blood coagulability. Both the AHA and BHF have issued cautionary
statements regarding this. This is of clinical interest as it could increase both perioperative blood
loss, and the risk of serious complications with certain anaesthetic techniques. Previous studies
investigating this effect have used older laboratory measures of coagulation which show little
correlation with clinical bleeding risk.
In the absence of good evidence disproving their theoretical suspicions, many surgeons and
anaesthetists may advise patients to discontinue fish oils for several days prior to surgery.
Given that the perioperative period is a time of increased cardiovascular risk, this decision is not
without risk to the patient.
We plan to investigate the effects of two different doses of fish oils on blood coagulation as
measured by several laboratory tests which have been shown to have a much stronger
correlation with clinical bleeding risk than traditional tests used in earlier studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34640 0
Address 34640 0
Country 34640 0
Phone 34640 0
Fax 34640 0
Email 34640 0
Contact person for public queries
Name 17887 0
Tomas Corcoran
Address 17887 0
Department of Anaesthesia and Pain medicine
Royal Perth Hospital
Wellington Street Campus
Perth
WA
6000
Country 17887 0
Australia
Phone 17887 0
+61 (08)9224 2244
Fax 17887 0
Email 17887 0
[email protected]
Contact person for scientific queries
Name 8815 0
Tomas Corcoran
Address 8815 0
Department of Anaesthesia and Pain medicine
Royal Perth Hospital
Wellington Street Campus
Perth
WA
6000
Country 8815 0
Australia
Phone 8815 0
+61 (08)9224 2244
Fax 8815 0
Email 8815 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.