THE JOURNAL OF JAPAN SOCIETY FOR CLINICAL ANESTHESIA
Online ISSN : 1349-9149
Print ISSN : 0285-4945
ISSN-L : 0285-4945
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The Reason Fibrinogen Concentrate Failed to Show Efficacy in Clinical Trials in Western Countries
Mutsuhito KIKURA
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2018 Volume 38 Issue 2 Pages 153-160

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Abstract

Randomized double-blind trials in western countries have failed to demonstrate the efficacy of fibrinogen concentrate(3-6 g)for perioperative hemostasis or demonstrate a reduction in blood transfusion in patients undergoing complicated cardiovascular surgery. The main reason for these negative findings in clinical trials is that the mean fibrinogen level of 170-180 mg/dL at the end of cardiopulmonary bypass is too high to induce the efficacy of fibrinogen concentrate and fresh frozen plasma is sufficiently effective for hemostasis in an area with a high level of fibrinogen. In our previous study, we demonstrated that the actual trigger level for fibrinogen concentrate was <130 mg/dL in thoracic aortic surgery, and the effective dose of fibrinogen was approximately 2-3 g per 50-70 kg in body weight. In the future, a new and safe approach that is based on objective study and clinical trials is sure to elucidate the trigger level and the effective dose of concentrated fibrinogen for patients undergoing cardiovascular surgery.

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© 2018 by The Japan Society for Clinical Anesthesia
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