Effects of Fish Oil on Platelet Function and Coagulation

NCT03048981 | Completed

• 1 other identifier: Fish oil and platelet function
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Aggregation, Spontaneous; Atherosclerosis; Surgery

Keywords

Thrombocyte aggregation; Fish oil; Alternative medicine; Point of care testing; Coagulation monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Coagulation measured with the viscohemostatic instrument ROTEM

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

• Coagulation measured with the viscohemostatic instrument and Sonoclot

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

Study Arms (1)

Fish oil intake

EXPERIMENTAL

Healthy volunteers given maximum dose of fish oil for 10 days.

Drug: Fish oil

Interventions

Fish oil DRUG

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

Fish oil intake

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non smoking healthy volunteers with written consent to participate

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Intensive and perioperative care. Skåne University Hospital. Lund

Lund, Skåne County, 22185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26887420 RESULT

MeSH Terms

Conditions

Platelet Aggregation, Spontaneous; Atherosclerosis

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Thomas Kander, MD, Phd

  Dept. of Clinical Sciences, Lund University, SWEDEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Before and after

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 9, 2017
• Study Start: March 1, 2017
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)