Effects of Fish Oil on Platelet Function and Coagulation

Not Applicable

Completed

• Conditions: Platelet Aggregation, Spontaneous; Atherosclerosis; Surgery
• Interventions: Drug: Fish oil

• Registration Number: NCT03048981
• Lead Sponsor: Region Skane

Brief 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. 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 Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-03-01
• Status Verified: 2017-05
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Non smoking healthy volunteers with written consent to participate

Exclusion Criteria

• Medication affecting coagulation or platelets within 14 days priori to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fish oil intake	Fish oil	Healthy volunteers given maximum dose of fish oil for 10 days.

Primary Outcome Measures

Name	Time	Method
Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips	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
Thrombocyte aggregation measured with multiple electrode aggregometry	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

Secondary Outcome Measures

Name	Time	Method
Coagulation measured with the viscohemostatic instrument and Sonoclot	Change of coagulation directly after intake period of 7 days compared to baseline	Viscohemostatic instrument
Coagulation measured with the viscohemostatic instrument ROTEM	Change of coagulation directly after intake period of 7 days compared to baseline	Viscohemostatic instrument

Trial Locations

Locations (1)

Intensive and perioperative care. Skåne University Hospital. Lund; 🇸🇪 Lund, Skåne, Sweden