Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil intake | Experimental | Healthy volunteers given maximum dose of fish oil for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil | Drug | Blood samples before and after 10 day intake of maximum dose fish oil |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Kander, MD, Phd | Dept. of Clinical Sciences, Lund University, SWEDEN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive and perioperative care. Skåne University Hospital. Lund | Lund | Skåne County | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26887420 | Result | 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. |
Not provided
Not provided
IPD will be available upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C566800 | Platelet Aggregation, Spontaneous |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
Not provided
Not provided
Before and after
Not provided
Not provided
Not provided
Not provided
Viscohemostatic instrument
| Change of coagulation directly after intake period of 7 days compared to baseline |