Effects of Fish Oil on Platelet Function and Coagulation (FOILP)

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Surgery; Platelet Aggregation, Spontaneous
• Intervention / Treatment: Drug: 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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22185
      • Intensive and Perioperative Care. Skåne University Hospital. Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fish oil intake; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coagulation measured with the viscohemostatic instrument ROTEM	Viscohemostatic instrument	Change of coagulation directly after intake period of 7 days compared to baseline
Coagulation measured with the viscohemostatic instrument and Sonoclot	Viscohemostatic instrument	Change of coagulation directly after intake period of 7 days compared to baseline

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Thomas Kander, MD, Phd, Dept. of Clinical Sciences, Lund University, SWEDEN

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): May 2, 2017
• Study Completion (ACTUAL): May 2, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (ESTIMATE): February 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Fish oil; Point of care testing; Alternative medicine; Coagulation monitoring; Thrombocyte aggregation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: Fish oil and platelet function

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No