In Reply Dr Meesters and colleagues are concerned about our choice of primary vs secondary outcomes. In our trial, patients with clinically relevant intraoperative bleeding after removal of cardiopulmonary bypass were randomized to receive placebo or fibrinogen concentrate. The moment of intervention was the start of the primary outcome, ending with closure of the chest. We expected that patients with severe coagulopathic bleeding would have relevant blood loss within this period, so it was chosen as the primary outcome. Because blood loss continues postoperatively, the cumulative 24-hour blood loss was chosen as the secondary outcome.
Bilecen S, Nierich A. Administration of Fibrinogen Concentrate During Cardiac Surgery—Reply. JAMA. 2017;317(24):2551-2552. doi:10.1001/jama.2017.6239