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

Phase 1

• 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.

• Registration Number: EUCTR2005-001007-18-GB
• Lead Sponsor: Royal Victoria Infirmary

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-18
• Study Completion: 2009-03-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.