Effects of Fish Oil on Platelet Function and Coagulation

NCT ID: NCT03048981

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Platelet Aggregation, Spontaneous Atherosclerosis Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before and after
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fish oil intake

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

Group Type EXPERIMENTAL

Fish oil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fish oil

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non smoking healthy volunteers with written consent to participate

Exclusion Criteria

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

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Skane

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Kander

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Kander, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Dept. of Clinical Sciences, Lund University, SWEDEN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Intensive and perioperative care. Skåne University Hospital. Lund

Lund, Skåne County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26887420 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Fish oil and platelet function

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Marine Oils and Arthritis
NCT00805116 TERMINATED NA