Gerandomiseerde vergelijkende studie naar verschillen tussen de biologische beschikbaarheid en de effectiviteit van vitamine K drank en vitamine K tabletten.
Recruiting
- Conditions
- Anticoagulants.Vitamin K antagonists.Vitamin KCoumarines.Vitamine K antagonisten.Vitamine K
- Registration Number
- NL-OMON26078
- Lead Sponsor
- eiden University Medical Center, Department of Thrombosis and Hemostasis
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
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;
Exclusion Criteria
1. Being treated for liver failure;
2. Pregancy, pregnancy wish or lactational period;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The difference between vitamin K levels in blood 4 hours after taking vitamin K tablets in comparison with vitamin K solution;<br /><br>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;<br /><br>3. Difference in the decrease of INRs 24 hours after taking either vitamin K tablets or solution.<br>The difference in the number of INRs lower than 2.0 when comparing vitamin K tablets and solution after 24 and 48 hours.
- Secondary Outcome Measures
Name Time Method 1. The difference between area under the curve measured over 24 hours after taking vitamin K tablets in comparisson with vitamin K solution;<br /><br>2. The difference in increase of the vitamin K levels in the blood 24 hours after taking either vitamin K tablets solution.