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

Phase 1
Conditions
Adult patients using acenocoumarol and planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed.
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Registration Number
EUCTR2018-002291-41-NL
Lead Sponsor
Gelderse Vallei Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

-Patients on acenocoumarol requiring an invasive procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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