This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

We will assess the benefits and harms of fibrinogen concentrate compared to placebo or usual treatment for bleeding patients. We will look at various outcomes, predefined subgroups and perform sensitivity analyses. We will also examine the role of bias and apply trial sequential analyses (TSA) (Wetterslev 2008) to examine the level of evidence. We will provide a 'Risk of bias' (ROB) table and a 'Summary of findings' (SOF) table in order to list important outcomes and quality of evidence (Guyatt 2008).