Non-malignant haematology Haematological Disorders
Conditions
Interventions
Eligible participants will be randomly allocated to receive a vitamin K "tailored" dose, or "fixed-dose" vitamin K regimen as per routine clinical practice (control arm).
All eligible patients wil
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients reaching the target INR range within 24 hours of receiving oral vitamin | — |
Secondary
| Measure | Time frame |
|---|---|
| The need for repeated doses of vitamin K, temporary resistance to warfarin | — |
Countries
United Kingdom
Outcome results
None listed