An interventional study of Fish oil in Platelet Aggregation, Spontaneous, Atherosclerosis and Surgery, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Region Skane · Not applicable, Interventional, and Basic science
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.
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.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 12 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
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Exclusion Criteria:
Healthy volunteers given maximum dose of fish oil for 10 days.
Drug: Fish oil
Blood samples before and after 10 day intake of maximum dose fish oil
Thrombocyte aggregation measured with multiple electrode aggregometry
Multiple electrode aggregometry gives a area under the curve proportional to thrombocyte aggregation
Time frame: 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
Time frame: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Coagulation measured with the viscohemostatic instrument ROTEM
Viscohemostatic instrument
Time frame: Change of coagulation directly after intake period of 7 days compared to baseline
Coagulation measured with the viscohemostatic instrument and Sonoclot
Viscohemostatic instrument
Time frame: Change of coagulation directly after intake period of 7 days compared to baseline
Plan to share: Yes — IPD will be available upon reasonable request
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Region Skane