Effects of Fish Oil on Platelet Function and Coagulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Fish Oil on Platelet Function and Coagulation

Conditions
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Platelet Aggregation, Spontaneous, Atherosclerosis, Surgery

Intervention / Treatment
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* Drug: Fish oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non smoking healthy volunteers with written consent to participate Exclusion Criteria: Medication affecting coagulation or platelets within 14 days priori to inclusion

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Before and after
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish oil intake<br>Healthy volunteers given maximum dose of fish oil for 10 days. | Drug: Fish oil<br>* Blood samples before and after 10 day intake of maximum dose fish oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombocyte aggregation measured with multiple electrode aggregometry | Multiple electrode aggregometry gives a area under the curve proportional to thrombocyte aggregation | 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 | Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulation measured with the viscohemostatic instrument ROTEM | Viscohemostatic instrument | Change of coagulation directly after intake period of 7 days compared to baseline | 
| Coagulation measured with the viscohemostatic instrument and Sonoclot | Viscohemostatic instrument | Change of coagulation directly after intake period of 7 days compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point of care testing, Coagulation monitoring, Thrombocyte aggregation, Fish oil, Alternative medicine