Skip to main content
OpenTrials
Completed

NCT Number: NCT03048981

Effects of Fish Oil on Platelet Function and Coagulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Platelet Aggregation, Spontaneous Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Surgery Vascular Diseases

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive and perioperative care. Skåne University Hospital. Lund

Lund, Skåne County, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non smoking healthy volunteers with written consent to participate

Exclusion criteria

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

Treatment and study plan

Fish oil

Drug

Blood samples before and after 10 day intake of maximum dose fish oil

Primary outcomes

  1. Thrombocyte aggregation measured with multiple electrode aggregometry

    Time frame: 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

  2. Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips

    Time frame: 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

Secondary outcomes

  1. Coagulation measured with the viscohemostatic instrument ROTEM

    Time frame: Change of coagulation directly after intake period of 7 days compared to baseline

    Viscohemostatic instrument

  2. Coagulation measured with the viscohemostatic instrument and Sonoclot

    Time frame: Change of coagulation directly after intake period of 7 days compared to baseline

    Viscohemostatic instrument

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: FOILP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.