Improving stability of anticoagulation through vitamin K

• Research type

  Research Study

• Full title

  Improving the safety and efficacy of anticoagulation therapy for thromboembolic disease through vitamin K

• IRAS ID

  9020

• Contact name

  Hilary A Wynne

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2008-006238-87

• ISRCTN Number

  n/a

• Research summary

  Anticoagulation (blood thinning) with warfarin is useful for the prevention and treatment of blood clotting. People taking the drug have to have regular blood tests to make sure that their blood neither clots too easily nor too slowly, so that clots are prevented but bleeding is prevented as much as possible. We have shown that taking a small amount of vitamin K with warfarin makes a substantial improvement in clotting control in patients with unstable control. We suspect that clotting control for the whole anticoagulated patient population could be improved by using this approach. We will test this by giving a small amount of vitamin K (150 æg) as a capsule or matching placebo (dummy capsule) daily to a group of patients shortly after starting warfarin for a six month period. Eligible patients will be those who will be taking warfarin for at least six months, and have the most usual target range for anticoagulation (clotting test (INR) of 2.3). From 6 weeks to 6 months we will compare INR results, and the number of changes in warfarin dose between the two groups of patients. The study will involve having an INR measured after one week and at least every four weeks, according to stability, which for some patients might be more often than usual and for some less so.If the vitamin K supplementation is shown to be of benefit, then this would be an easily introduced intervention which would quickly lead to improved care and outcome for many patients requiring anticoagulation therapy.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  09/H0904/25

• Date of REC Opinion

  8 Jun 2009

• REC opinion

  Further Information Favourable Opinion