Randomised trial to investigate possible differences in biological availability and effectiveness between vitamin K solution in oil and vitamin K tablets.

Phase 4

Completed

• Conditions: normalising the INR; Reducing the INR; 10064477

• Registration Number: NL-OMON39217
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-09-06
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 194

Inclusion Criteria

Age above 18.

Exclusion Criteria

Liver failure
Dialysis (both hemodialysis and peritoneal dialysis)
Pregnancy, pregnancy wish or breastfeeding.
Participation in the self management program
Inability to manage medication intake or proven (previously) non-compliance with treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Healthy volunteers:<br /><br>Difference in the ammount of vitamin K in the blood at different times between<br /><br>the vitamin K tablets en solution. Also we will examine the area under the<br /><br>curve for the entire period of 24 hours.<br /><br><br /><br>Patients undergoing (small) elective surgery / invasive diagnostic procedure:<br /><br>The difference in the number of INR-values beneath 2.0 between both groups<br /><br>after 24 and 48 hours.<br /><br><br /><br>Patients having an INR between 7.0 and 10.0:<br /><br>The difference in INR reduction between both groups after 24 and 48 hours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patients having an INR between 7.0 and 10.0:<br /><br>The difference in the number of INR-values beneaht 2.0 after 24 and 48 hours<br /><br>between both groups.<br /><br>The difference of the ammount of vitamin K in the blood between both groups.</p><br>