Reversal of over-anticoagulation with vitamin K

Not Applicable

Completed

• Conditions: on-malignant haematology; Haematological Disorders

• Registration Number: ISRCTN79841657
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28771671

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-10
• Study Completion: 2013-12-31
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1. Patients on chronic therapy on warfarin presenting with an INR equal or greater than 6.0
2. Patient has provided written informed consent for participation in the study prior to any study specific procedures
3. 18 years of age or over
4. Male & female particpants

Exclusion Criteria

1. Younger than 18 years
2. Life expectancy less than 10 days
3. Presence of major bleeding requiring immediate and complete correction of anticoagulation
4. A history of thromboembolic / major haemorrhagic event in the previous 3 months
5. nown bleeding disorder
6. Known sensitivity to vitamin K
7. Liver disease
8. Indication for acute normalisation of INR (such as imminent surgery)
9. Scheduled discontinuation of warfarin therapy
10. Receiving thrombolytic therapy within 48 hours
11. A platelet count less than 50x10 x 9 (superscript) cells/L
12. Unable to take oral medication
13. Unable to return to the clinic the next day for laboratory/clinical assessment
14. Participation in any other investigational study/trial within the past month

Study & Design

• Study Type: Interventional
• Study Design: Not specified