This multicentre randomised non-inferiority trial was conducted for assess whether critically ill patients with a mild-to-moderate coagulopathy (INR 1.5-3.0) undergoing an invasive procedure may benefit from prophylactic transfusion of low-dose (12 mL/kg) fresh frozen plasma (FFP). Patients were randomly assigned to receive FFP (transfused group) or not (non-transfused group). The primary endpoint was the occurrence of procedure-related major bleeding within 24 hours after the procedure.
Due to slow enrollment, the trial was stopped before the target sample size of 198 patients per group was reached, and 38 patients in each group were included in the analysis. Only one case of major bleeding occurred (in the non-transfused group). The incidence of
bleeding (major or minor) did not differ between groups (8 in the non-transfused group versus 6 in the transfused group: p=0.77). Moreover, FFP transfusion failed to decrease INR in about half of transfused patients. The rate of nosocomial pneumonia and the days of mechanical ventilation were both higher in transfused patients.
The authors conclude that the occurrence of bleeding complications after an invasive procedure in critically ill patients with a coagulopathy did not differ with or without prophylactic FFP transfusion. However, as mentioned by authors, this study has important limitations. First, due to the limited sample size, the non-inferiority of withholding FFP transfusion could not be demonstrated. Second, although no difference in bleeding was observed, patients who did not receive prophylactic FFP transfusion received a median of 2 units of FFP within 24 hours after the procedure. Third, the dose of FFP used in this study may have been too low to demonstrate a significant decrease in haemorrhagic complications.
– Santiago Ramón Leal-Noval
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