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

Simon J Stanworth, Beverley J Hunt

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.