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Evidence-Based Medicine 2009;14:112; doi:10.1136/ebm.14.4.112
Copyright © 2009 by the BMJ Publishing Group Ltd.

THERAPEUTICS

Oral vitamin K did not reduce bleeding in patients with excessive anticoagulation after receiving warfarin

The first 150 words of the full text of this article appear below.


STUDY DESIGN

Design:

randomised, placebo-controlled trial. ClinicalTrials.gov NCT00143715 [ClinicalTrials.gov] .

Allocation:

concealed.*

Blinding:

blinded (patients, clinicians, research coordinators, and outcome adjudicators).*


STUDY QUESTION

Setting:

14 anticoagulant centres in the USA, Canada, and Italy.

Patients:

724 outpatients >=18 years of age (mean age 69 y, 53% men) who attended clinic for routine international normalised ratio (INR) assessment, were receiving warfarin with a target INR of 2.0–3.5, were not bleeding, and had an INR between 4.5 and 10.0 in the past 24 hours. Exclusion criteria included life expectancy <10 days, indication for acute normalisation of INR, scheduled discontinuation of warfarin, known bleeding disorder, recent major bleeding, inability to take oral medication or undergo follow-up, contraindication to vitamin K, severe liver disease, thrombolytic therapy within 48 hours, and platelet count <50 x 109 cells/l.

Intervention:

single-dose oral vitamin K, 1.25 mg (n = 355), or placebo (n = 369).

Outcomes:

any bleeding events at 90 days. Secondary outcomes included major bleeding (fatal bleeding, bleeding requiring . . . [Full text of this article]

Matthew Rondina

University of Utah, Salt Lake City, Utah, USA


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