The effect of administering VITamin K preprocedural on the vitamin K dependent coagulation factors and the INR in patients anticoagulated with ACEnocoumarol (VITKACE-study)

Phase 4

Recruiting

• Conditions: stollingsfysiologie; invasive procedure; oral anticoagulation

• Registration Number: NL-OMON46375
• Lead Sponsor: Ziekenhuisvoorzieningen Gelderse Vallei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Patients on acenocoumarol requiring an invasive procedure

Exclusion Criteria

- Age < 18 years.
- Patients requiring periprocedural bridging therapy according to our local protocol based on national guidelines with low-molecular-weight-heparin (LMWH).
- Inherited or acquired coagulopathies.
- Inability or incompetency to give informed consent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Plasma concentrations of prothrombin and factor VII at the day of the invasive<br /><br>procedure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The number of patients with an INR <1.8 just prior to the invasive procedure.<br /><br>- Number of thromboembolic or bleeding events occurring within 30 days after<br /><br>the intervention.<br /><br>- Time to achieve therapeutic INR in acenocoumarol users who are administered a<br /><br>single dose of vitamin K 36-48 hours before the invasive procedure.<br /><br>- Pharmacogenetic variation between the patients that reach an adequate INR and<br /><br>those that don't.</p><br>