Anticoagulants. Vitamin K antagonists. Vitamin K Coumarines. Vitamine K antagonisten. Vitamine K
Conditions
Interventions
Administration of vitamin K tablets or solution.
Sponsors
Leiden University Medical Center, Department of Thrombosis and Hemostasis
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects; 2. Patients being treated with phenprocoumon undergoing an invasive diagnostic or therapeutic procedure for which reducing of the INR is necessary; 3. Patients being treated with phenprocoumon having an INR above 7.0 for which reducing with vitamin K is necessary; 4. Age 18 years or older; 5. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Being treated for liver failure; 2. Pregancy, pregnancy wish or lactational period; 3. Hemodialysis or peritoneal dialysis; 4. Participation in the self management program; 5. Inability to take care of own medication and/or proven non-compliance with treatment protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The difference between vitamin K levels in blood 4 hours after taking vitamin K tablets in comparison with vitamin K solution; 2. The difference in the number of INR-values lower than 2.0 when comparing vitamin K tablets with vitamin K solution in oil after 24 and 48 hours; 3. Difference in the decrease of INRs 24 hours after taking either vitamin K tablets or solution. The difference in the number of INRs lower than 2.0 when comparing vitamin K tablets and solution after 24 and 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference between area under the curve measured over 24 hours after taking vitamin K tablets in comparisson with vitamin K solution; 2. The difference in increase of the vitamin K levels in the blood 24 hours after taking either vitamin K tablets solution. | — |
Contacts
Public ContactFelix J.M. Meer, van der
Leiden University Medical Center (LUMC), Department of Hematology, P.O. Box 9600
Outcome results
None listed