Clinical trial NCT03048981: Effects of Fish Oil on Platelet Function and Coagulation
Official title: Effects of Fish Oil on Platelet Function and Coagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Aggregation, Spontaneous
Atherosclerosis
Surgery
Keywords: Thrombocyte aggregation
Fish oil
Alternative medicine
Point of care testing
Coagulation monitoring
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Non smoking healthy volunteers with written consent to participate

Exclusion Criteria:

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

Primary outcomes:
measure: Thrombocyte aggregation measured with multiple electrode aggregometry
timeFrame: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
measure: Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips
timeFrame: Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Secondary outcomes:
measure: Coagulation measured with the viscohemostatic instrument ROTEM
timeFrame: Change of coagulation directly after intake period of 7 days compared to baseline
measure: Coagulation measured with the viscohemostatic instrument and Sonoclot
timeFrame: Change of coagulation directly after intake period of 7 days compared to baseline
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Intensive and perioperative care. Skåne University Hospital. Lund
state: Skåne
Study officials:
affiliation: Dept. of Clinical Sciences, Lund University, SWEDEN
name: Thomas Kander, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.