Assessment of the efficacy of a novel tailored vitamin K dosing regimen in lowering the International Normalised Ratio in over-anticoagulated patients: a randomised clinical trial

Br J Haematol. 2017 Sep;178(5):800-809. doi: 10.1111/bjh.14777. Epub 2017 Aug 2.

Abstract

Current guidelines advocate using fixed-doses of oral vitamin K to reverse excessive anticoagulation in warfarinised patients who are either asymptomatic or have minor bleeds. Over-anticoagulated patients present with a wide range of International Normalised Ratio (INR) values and response to fixed doses of vitamin K varies. Consequently a significant proportion of patients remain outside their target INR after vitamin K administration, making them prone to either haemorrhage or thromboembolism. We compared the performance of a novel tailored vitamin K dosing regimen to that of a fixed-dose regimen with the primary measure being the proportion of over-anticoagulated patients returning to their target INR within 24 h. One hundred and eighty-one patients with an index INR > 6·0 (asymptomatic or with minor bleeding) were randomly allocated to receive oral administration of either a tailored dose (based upon index INR and body surface area) or a fixed-dose (1 or 2 mg) of vitamin K. A greater proportion of patients treated with the tailored dose returned to within target INR range compared to the fixed-dose regimen (68·9% vs. 52·8%; P = 0·026), whilst a smaller proportion of patients remained above target INR range (12·2% vs. 34·0%; P < 0·001). Individualised vitamin K dosing is more accurate than fixed-dose regimen in lowering INR to within target range in excessively anticoagulated patients.

Keywords: anticoagulation; bleeding; thrombosis; vitamin K; warfarin.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticoagulants / adverse effects*
  • Antifibrinolytic Agents / administration & dosage*
  • Blood Coagulation / drug effects*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Hemorrhage / blood
  • Hemorrhage / chemically induced
  • Hemorrhage / prevention & control
  • Humans
  • International Normalized Ratio*
  • Male
  • Middle Aged
  • Thromboembolism / blood
  • Thromboembolism / etiology
  • Thromboembolism / prevention & control
  • Treatment Outcome
  • Vitamin K / administration & dosage*
  • Warfarin / adverse effects*
  • Young Adult

Substances

  • Anticoagulants
  • Antifibrinolytic Agents
  • Vitamin K
  • Warfarin