Critical Care

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Commentary

The desperate need for good-quality clinical trials to evaluate the optimal source and dose of fibrinogen in managing bleeding

Simon J Stanworth1 and Beverley J Hunt2,3*

Author Affiliations

1 NHS Blood and Transplant/Oxford Radcliffe Hospitals Trust, John Radcliffe Hospital, Oxford, OX3 9BQ, UK

2 Department of Thrombosis and Haemostasis, King's College, London, UK

3 Guy's and St Thomas' NHS Foundation Trust, Thrombosis and Haemophilia Centre, St Thomas' Hospital, London, SE1 7EH, UK

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Critical Care 2011, 15:1006 doi:10.1186/cc10510


See related research by Kozek-Langenecker et al., http://ccforum.com/content/15/5/R239 and related letter by Kozek-Langenecker et al., http://ccforum.com/content/15/6/462.

Published: 11 November 2011

Abstract

Recent interest in transfusion management of trauma patients has heightened expectation in the role of blood component therapy in improving patient outcome. Optimal transfusion support in supplementation with fibrinogen has not been defined by high-quality evidence. Current evidence comes mainly from case series and uncontrolled studies and does not support the superiority of one source of fibrinogen over another or the optimal schedule or dose for patient benefit. There are unanswered questions about safety, especially the effects on the risk of hospital-acquired venous thromboembolism, an important consideration in any therapy that alters the hemostatic balance. Studies of cost-effectiveness have not been considered in research. An international move to supplement fibrinogen more 'aggressively' without direct clinical evaluation beforehand represents a failed opportunity to improve our very limited understanding of optimal transfusion practice.