Reversal of warfarin anticoagulation with oral vitamin K: towards a better management of over-anticoagulation - Reversal of warfarin anticoagulation with oral vitamin K

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001007-18-GB

Enrollment

140

Registered

2005-04-18

Start date

2005-06-03

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with thromboembolic disorders are anticogulated with warfarin. However excessive over-anticoagulation can increase the patient risk of bleeding. Oral vitamin K is routinely used for reversal of over-anticoagulation. This study will investigate the effectiveness of a new ‘tailored’ vitamin K dosing regimen based on individual patient INR, compared to the 'conventional' dosing regimen in the reversal of warfarin over-anticoagulation.

Interventions

Trade Name: Vitamin K (Konakion) Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All over-anticoagulated patients will be eligible to participate if they are receiving warfarin with a target INR range of 2-3, irrespective of the duration of warfarin treatment. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients will be excluded if they meet one or more of the following criteria: 1) presence of major bleeding requiring immediate and complete correction of anticoagulation, 2) a history of thromboembolic / major haemorrhagic event in the previous 3 months, 3) the primary reason for anticoagulation is prosthetic heart valve, 4) known sensitivity to vitamin K, 5) liver disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effectiveness of a new ‘tailored’ vitamin K dosing regimen based on individual patient INR, in the reversal of warfarin over-anticoagulation. ;Secondary Objective: To determine, retrospectively, the impact of patient age, gender, body weight, co-morbidity, frailty, warfarin daily dose and Vitamin K epoxide reductase complex subunit 1 gene (VKORC1) polymorphism on the rate and extent of INR reversal.;Primary end point(s): Patient INR to target 2-3.	—

Measure

Time frame

Main Objective: To assess the effectiveness of a new ‘tailored’ vitamin K dosing regimen based on individual patient INR, in the reversal of warfarin over-anticoagulation. ;Secondary Objective: To determine, retrospectively, the impact of patient age, gender, body weight, co-morbidity, frailty, warfarin daily dose and Vitamin K epoxide reductase complex subunit 1 gene (VKORC1) polymorphism on the rate and extent of INR reversal.;Primary end point(s): Patient INR to target 2-3.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026