For continuous variables, normal distribution was analysed by the Shapiro-Wilk test. To detect differences between the patient groups, either the Student’s t-test or the Mann-Whitney U test was performed, depending on the underlying distribution. For categorical selleck kinase inhibitor variables, Fisher’s exact test was used. Statistics were calculated using IBM SPSS Statistics 18 (SPSS Inc., Chicago, IL, USA).ResultsIn the fibrinogen-PCC group, 80 of 353 patients treated in the STC between 2005 and 2009 fulfilled the inclusion criteria. Between 2005 and 2008 (data for 2009 were not available at the time of analysis), 21,263 patients were included in the TR-DGU. Of 21,263 patients, 2,582 fulfilled the general inclusion criteria. At this step, most cases were lost due to missing base deficit values.
After applying the specific haemostatic therapy criteria (Table (Table1),1), 601 patients could be included in the FFP group.Demographic data and trauma scores were available for all patients included in the study. As intended, the two groups were comparable with regard to demographic parameters as well as the overall magnitude of injury sustained and probability of survival assessed by the TRISS and RISC scores (Table (Table2).2). With regard to the pattern of injury, patients in the FFP group had sustained head and thoracic injuries of higher magnitude, whereas fibrinogen-PCC patients had sustained more severe abdominal injuries. Patients in the fibrinogen-PCC group also appeared to be less haemodynamically stable upon arrival at the ER. Standard laboratory coagulation data were available for at least 90% of the patients included in the study.
A significantly more prolonged prothrombin time (PT) was observed in the fibrinogen-PCC group (P = 0.0001; Table Table3);3); this difference was apparent upon arrival at the ICU as well as the ER. The base deficit also differed between the groups (6.4 �� 3.4 in the fibrinogen-PCC group and 6.9 �� 4.5 mmol/L in the FFP group), but this difference did not reach statistical significance.Table 2Patient demographic and clinical dataTable 3Standard laboratory parametersRBC transfusion data for treatment in the ER and during surgery were available for all patients. Complete avoidance of RBC transfusion was observed in 3% of patients in the FFP group and 29% of patients in the fibrinogen-PCC AV-951 group (P< 0.0001; Figure Figure1).1). In the FFP group, 583 of 601 patients (97%) received RBC transfusion (number of units ranging between 1 and 64), compared with 57 of 80 patients (71%) in the fibrinogen-PCC group (range: 1 to 28 units). Information on platelet concentrate transfusion for treatment in the ER and during surgery was available for 371 of the 601 patients in the FFP group, and for all patients in the fibrinogen-PCC group.