Back to resultsEffects of Fish Oil on Platelet Function and Coagulation (FOILP)
Primary Purpose
Platelet Aggregation, Spontaneous, Atherosclerosis, Surgery
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Fish oil
Sponsored by
About this trial
This is an interventional basic science trial for Platelet Aggregation, Spontaneous focused on measuring Thrombocyte aggregation, Fish oil, Alternative medicine, Point of care testing, Coagulation monitoring
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
Sites / Locations
- Intensive and perioperative care. Skåne University Hospital. Lund
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fish oil intake
Arm Description
Healthy volunteers given maximum dose of fish oil for 10 days.
Outcomes
Primary Outcome Measures
Thrombocyte aggregation measured with multiple electrode aggregometry
Multiple electrode aggregometry gives a area under the curve proportional to thrombocyte aggregation
Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips
Cellix's microfluidic pumps and biochips gives an thrombosis area proportional to thrombocyte aggregation
Secondary Outcome Measures
Coagulation measured with the viscohemostatic instrument ROTEM
Viscohemostatic instrument
Coagulation measured with the viscohemostatic instrument and Sonoclot
Viscohemostatic instrument
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03048981
Brief Title
Effects of Fish Oil on Platelet Function and Coagulation
Acronym
FOILP
Official Title
Effects of Fish Oil on Platelet Function and Coagulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
May 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Aggregation, Spontaneous, Atherosclerosis, Surgery
Keywords
Thrombocyte aggregation, Fish oil, Alternative medicine, Point of care testing, Coagulation monitoring
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil intake
Arm Type
Experimental
Arm Description
Healthy volunteers given maximum dose of fish oil for 10 days.
Intervention Type
Drug
Intervention Name(s)
Fish oil
Intervention Description
Blood samples before and after 10 day intake of maximum dose fish oil
Primary Outcome Measure Information:
Title
Thrombocyte aggregation measured with multiple electrode aggregometry
Description
Multiple electrode aggregometry gives a area under the curve proportional to thrombocyte aggregation
Time Frame
Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Title
Thrombocyte aggregation measured with Cellix's microfluidic pumps and biochips
Description
Cellix's microfluidic pumps and biochips gives an thrombosis area proportional to thrombocyte aggregation
Time Frame
Change of thrombocyte aggregation directly after intake period of 7 days compared to baseline
Secondary Outcome Measure Information:
Title
Coagulation measured with the viscohemostatic instrument ROTEM
Description
Viscohemostatic instrument
Time Frame
Change of coagulation directly after intake period of 7 days compared to baseline
Title
Coagulation measured with the viscohemostatic instrument and Sonoclot
Description
Viscohemostatic instrument
Time Frame
Change of coagulation directly after intake period of 7 days compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kander, MD, Phd
Organizational Affiliation
Dept. of Clinical Sciences, Lund University, SWEDEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive and perioperative care. Skåne University Hospital. Lund
City
Lund
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available upon reasonable request
Citations:
PubMed Identifier
26887420
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.
Results Reference
result
Learn more about this trial
Effects of Fish Oil on Platelet Function and Coagulation
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