Does low dose oral vitamin K reduce the risk of bleeding, without causing thrombosis, in patients with warfarin-associated coagulopathy: a randomised clinical trial

Not Applicable

Completed

• Conditions: Coagulopathy due to warfarin therapy; Haematological Disorders; Other coagulation defects

• Registration Number: ISRCTN16632843
• Lead Sponsor: Canadian Institutes of Health Research (CIHR) (Canada)

Brief Summary

1. 2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19258557 (added 31/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-22
• Study Completion: 2007-09-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1. 660 patients of either sex
2. Aged 18 and over
3. With International Normalised Ratio (INR) values of 4.5 to 10.0 and for cohort study: patients with INR values greater than 10

Exclusion Criteria

1. Active bleeding
2. Geographic inaccessibility and lack of informed consent
3. Age less than 18 years
4. Warfarin is being discontinued
5. Vitamin K allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with bleeding in each arm.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Major haemorrhage, or all clinically overt hemorrhage thrombosis and a composite of these two measures<br> 2. Changes in INR values<br> 3. Cost effectiveness<br>