10mg versus 5mg initiation dose of Warfarin to achieve adequate anticoagulation in the treatment of acute deep vein thrombosis: A Randomized Control Trial

Srujan, Lam Sharma (2016) 10mg versus 5mg initiation dose of Warfarin to achieve adequate anticoagulation in the treatment of acute deep vein thrombosis: A Randomized Control Trial. Masters thesis, Christian Medical College, Vellore.

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Abstract

INTRODUCTION: Current practices in the treatment of acute deep vein thrombosis involve oral anticoagulation to maintain an INR between 2 and 3, most commonly with Warfarin. Researchers have tried to establish how best to achieve this target quickly, safely and effectively but with varying results. This study aims to determine if a 10mg initial dose of warfarin achieves adequate anticoagulation faster than initiation with a 5mg dose. METHODS: A randomized control trial was performed on inpatients diagnosed to have acute deep vein thrombosis and being started on Warfarin. . Sample size calculated for a superiority trial, with alpha value 5%, power 95%, with 10mg reaching primary end point by 4.2 days and 5mg reaching same by 5.6 days and a standard deviation of 1.4 days, and no predicted cross-over is 26 in each arm, or 52 in total. A target sample size of 60 was decided to account for attrition. Consenting participants who met selection criteria were randomly allocated to either a 10mg initiation group or a 5mg initiation group and received therapy accordingly. The patients were monitored until they reached the primary end point of two consecutive INR values between 2 and 3, or a secondary end point such as death, bleeding complication or withdrawal from the study. RESULTS AND CONCLUSION: The 10mg arm of the trial reached therapeutic INR value faster than the 5mg arm with a p-value of 0.02. There was no statistically significant increased risk of bleeding in either arm. Further studies however are required before these results can be translated to changes in clinical practice guidelines.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Warfarin ; Randomized Control Trial ; Loading Dose ; Deep Vein Thrombosis.
Subjects: MEDICAL > General Surgery
Depositing User: Subramani R
Date Deposited: 12 Oct 2017 01:04
Last Modified: 12 Oct 2017 01:04
URI: http://repository-tnmgrmu.ac.in/id/eprint/3558

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