Platelet Aggregation, SpontaneousFOILPNCT03048981
Effects of Fish Oil on Platelet Function and Coagulation
A study testing Fish oil in people with Platelet Aggregation, Spontaneous and Atherosclerosis, run by Region Skane at 1 site in Sweden.
Trial summary
Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has been reported to increase bleeding in patients through inhibiting platelet aggregation and prolonging of clot formation time. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Aggregation, Spontaneous, Atherosclerosis, Surgery
- What is being tested?
- Fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2017to 2 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non smoking healthy volunteers with written consent to participate
Who cannot join
- Medication affecting coagulation or platelets within 14 days priori to inclusion
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Intensive and perioperative care. Skåne University Hospital. Lund
Lund, Skåne County, 22185
About this study
Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has been reported to increase bleeding in patients through inhibiting platelet aggregation and prolonging of clot formation time. The Swedish Medical Products Agency recommends that patients stop taking the naturopathic medicines including fish oil two weeks prior planed surgery. The aim of this study is to examine the effects of fish oil given to healthy volunteers using point of care coagulation assessment and flow dependent Cellix instrument before and after intake of fish oil.
Read the detailed description
Healthy volunteers will be given maximum dose of fish oil for 7 days. Blood samples will be collected before and immediately after the 7 days of intake and analysed using point of care coagulation assessment instruments and flow dependent platelet aggregation using a microfluid flow controlled system (Cellix). For point of care coagulation assessment the multiple electrode platelet aggregometer Multiplate, the viscoelastic rotational thromboelastometers ROTEM and Sonoclot will be used. Flow cytometry may also be utilized.
- Conditions
- Platelet Aggregation, Spontaneous, Atherosclerosis, Surgery
- Being tested
- Fish oil
- Keywords
- Thrombocyte aggregation, Fish oil, Alternative medicine, Point of care testing, Coagulation monitoring
- Medical subject headings
- Platelet Aggregation, Spontaneous, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oilDrug
Blood samples before and after 10 day intake of maximum dose fish oil
| Study group | Role | What they receive |
|---|---|---|
| Fish oil intake | Experimental | Healthy volunteers given maximum dose of fish oil for 10 days. Receives: Drug: Fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombocyte aggregation measured with multiple electrode aggregometry
Multiple electrode aggregometry gives a area under the curve proportional to thrombocyte aggregation
Measured: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips
Cellix's microfluidic pumps and biochips gives an thrombosis area proportional to thrombocyte aggregation
Measured: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Secondary outcomes (2)
Coagulation measured with the viscohemostatic instrument ROTEM
Viscohemostatic instrument
Measured: Change of coagulation directly after intake period of 7 days compared to baseline
Coagulation measured with the viscohemostatic instrument and Sonoclot
Viscohemostatic instrument
Measured: Change of coagulation directly after intake period of 7 days compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet Aggregation, SpontaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Kander, Region Skane
- Investigators
- Thomas Kander, MD, Phd, Principal investigator, Dept. of Clinical Sciences, Lund University, SWEDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048981
- Sponsor's protocol ID
- Fish oil and platelet function
- Acronym
- FOILP
- Status last verified
- May 2017
- First submitted
- 2 Feb 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon reasonable request
Publications
Bagge A, Schott U, Kander T. Effects of naturopathic medicines on Multiplate and ROTEM: a prospective experimental pilot study in healthy volunteers. BMC Complement Altern Med. 2016 Feb 17;16:64. doi: 10.1186/s12906-016-1051-y.
PubMed 26887420
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fish Oil on Platelet Function and Coagulation
- ClinicalTrials.gov ID
- NCT03048981
- Acronym / sponsor ID
- FOILP / Fish oil and platelet function
- Conditions
- Platelet Aggregation, Spontaneous, Atherosclerosis, Surgery
- Keywords
- Thrombocyte aggregation, Fish oil, Alternative medicine, Point of care testing, Coagulation monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients undergoing surgery use naturopathic drugs, including fish oil. Fish oil has been reported to increase bleeding in patients through inhibiting platelet aggregation and prolonging of clot formation time. The Swedish Medical Products Agency recommends that patients stop taking the naturopathic medicines including fish oil two weeks prior planed surgery. The aim of this study is to examine the effects of fish oil given to healthy volunteers using point of care coagulation assessment and flow dependent Cellix instrument before and after intake of fish oil.
Detailed description
Healthy volunteers will be given maximum dose of fish oil for 7 days. Blood samples will be collected before and immediately after the 7 days of intake and analysed using point of care coagulation assessment instruments and flow dependent platelet aggregation using a microfluid flow controlled system (Cellix). For point of care coagulation assessment the multiple electrode platelet aggregometer Multiplate, the viscoelastic rotational thromboelastometers ROTEM and Sonoclot will be used. Flow cytometry may also be utilized.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after
| Arm | Type | Receives |
|---|---|---|
| Fish oil intake | Experimental | Drug: Fish oilHealthy volunteers given maximum dose of fish oil for 10 days. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non smoking healthy volunteers with written consent to participate
Key exclusion criteria (1 listed)
- Medication affecting coagulation or platelets within 14 days priori to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oilBlood samples before and after 10 day intake of maximum dose fish oil | Drug | Fish oil intake |
Primary outcome
Thrombocyte aggregation measured with multiple electrode aggregometry
Time frame: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Multiple electrode aggregometry gives a area under the curve proportional to thrombocyte aggregation
Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips
Time frame: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Cellix's microfluidic pumps and biochips gives an thrombosis area proportional to thrombocyte aggregation
2 secondary outcomes
Coagulation measured with the viscohemostatic instrument ROTEM
Time frame: Change of coagulation directly after intake period of 7 days compared to baseline
Coagulation measured with the viscohemostatic instrument and Sonoclot
Time frame: Change of coagulation directly after intake period of 7 days compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Results publication: PubMed 26887420Bagge A, Schott U, Kander T. Effects of naturopathic medicines on Multiplate and ROTEM: a prospective experimental pilot study in healthy volunteers. BMC Complement Altern Med. 2016 Feb 17;16:64. doi: 10.1186/s12906-016-1051-y.
- Individual participant dataSharing planned: Yes. IPD will be available upon reasonable request
Related trials for Platelet Aggregation, Spontaneous
Active, not recruiting
The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation
Platelet Aggregation, Spontaneous, Vascular Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kander, MD, Phd principal investigator
Dept. of Clinical Sciences, Lund University, SWEDEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil in people with Platelet Aggregation, Spontaneous and Atherosclerosis, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombocyte aggregation measured with multiple electrode aggregometry (time frame: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048981, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.