Coagulation managementIn the fibrinogen-PCC group, coagulation management was guided by TEM analysis [12]. Haemostatic therapy comprised administration of 2 to 4 g of fibrinogen concentrate (first-line therapy for patients needing increased firmness of the fibrin-based clot), and administration of 1,000 to 1,500 U of PCC, for patients showing prolonged clotting product information time in the thromboelastometry EXTEM test (> 1.5 times normal) [12]. This treatment was repeated as necessary. Fibrinogen concentrate was administered using two to four automatic infusion systems (Perfusor?, B. Braun, Melsungen, Germany) working in parallel, each at a rate of 200 mL/h; for each infusion system, 1 g of fibrinogen concentrate was diluted in 50 mL of water for injections. The resulting administration rate was 2 to 4 g in 15 minutes.

For patients in whom fibrinogen could not fully compensate for decreased platelet levels, platelet concentrate was transfused (platelet concentrate was recommended if the EXTEM-MCF is decreased to < 40 mm when FIBTEM-MCF is 10 to 12 mm). The target haemoglobin concentration during the operative procedure was 10 g/dL. In the postoperative phase, lower haemoglobin levels were tolerated.Coagulation management of patients in the FFP group was dictated by clinical practice at each trauma department and was therefore not standardised. TEM is not used in standard practice; nevertheless, isolated use in some hospitals means that a minority of patients in the registry may have been treated with some TEM guidance.

Although the treatment of patients in the TR-DGU is not standardised, it represents the general approach to coagulation management of major trauma patients in Germany, with FFP administered as first-line haemostatic therapy, and platelet concentrate and RBC used as necessary. Laboratory analyses of coagulation were performed in the local laboratories; the register collects no information on the type of analyses, reagents or devices on which they are performed, or on their role in guiding haemostatic therapy within the local protocol.Selection of variables for analysisFor all subjects, age and gender were documented together with the following parameters upon admission: coagulation results, blood pressure, heart rate, temperature, ISS and Glasgow coma scale score. Predicted mortality for each patient was estimated using the RISC and the TRISS methodology.

Mortality rate (until discharge from the hospital) was documented.Details of coagulation management were noted for the acute phase (ER and Carfilzomib early surgery phase) and the first 48 hours spent in the ICU. For the fibrinogen-PCC group, administration of RBC, fibrinogen concentrate, PCC and platelet concentrate were noted for both time periods. For the FFP group, administration of RBC and FFP were noted for both time periods; data for platelet concentrate administration were only available for the acute phase.