Effects of Fish Oil on Platelet Function and Coagulation

Surgery Clinical Trial

— FOILP  

Official title:

Effects of Fish Oil on Platelet Function and Coagulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048981
• Other study ID #: Fish oil and platelet function
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: May 5, 2017
• Start date: March 1, 2017
• Est. completion date: May 2, 2017

Study information

• Verified date: May 2017
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

• Non smoking healthy volunteers with written consent to participate

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Atherosclerosis
• Blood Platelet Disorders
• Platelet Aggregation, Spontaneous
• Surgery

Intervention

Drug:
• Fish oil
Blood samples before and after 10 day intake of maximum dose fish oil

Locations

Country	Name	City	State
Sweden	Intensive and perioperative care. Skåne University Hospital. Lund	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bagge A, Schött 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Coagulation measured with the viscohemostatic instrument ROTEM	Viscohemostatic instrument	Change of coagulation directly after intake period of 7 days compared to baseline
Secondary	Coagulation measured with the viscohemostatic instrument and Sonoclot	Viscohemostatic instrument	Change of coagulation directly after intake period of 7 days compared to baseline