Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study

Abstract

Background: Low plasma fibrinogen concentration is a predictor of poor outcome in major trauma patients. The role of fibrinogen concentrate for rapidly increasing fibrinogen plasma levels in severe trauma is not well defined.

Methods: In this retrospective study we included severe trauma patients treated with fibrinogen concentrate alone (FC group), fibrinogen concentrate with prothrombin complex concentrate (FC-PCC group) or fibrinogen concentrate with PCC and fresh frozen plasma (FC-PCC-FFP group). PCC was generally administered as the second step of intraoperative therapy, while FFP was only administered as a third step. All patients received ≥1 g fibrinogen concentrate within 24 hours. Plasma fibrinogen concentration and ROTEM parameters upon emergency room (ER) admission, intensive care unit (ICU) admission, and after 24 hours were analysed.

Results: Among 157 patients fulfilling the inclusion criteria, 83% were male; mean age was 44 years and median injury severity score (ISS) was 29. Standard coagulation tests reflected increasing severity of coagulopathy with increasing complexity of haemostatic therapy (highest severity in the FC-PCC-FFP group; p < 0.0001). Total 24-hour fibrinogen concentrate dose also increased with complexity of haemostatic therapy. Plasma fibrinogen concentration was maintained, with no significant difference between ER admission and ICU admission in all patient groups. FIBTEM clot firmness at 10 minutes (CA10) was similarly maintained, albeit with a small increase in the FC-PCC group. Fibrinogen concentration and FIBTEM CA10 were within the normal range in all groups at 24 hours. The ratio of fibrinogen concentrate to red blood cells (g:U) ranged between 0.7:1.0 and 1.0:1.0.

Conclusion: Fibrinogen concentrate therapy maintained fibrinogen concentration and FIBTEM CA10 during the initial phase of trauma care until ICU admission. After 24 hours, these parameters were comparable between the three groups and within the normal range for each of them. Further studies are warranted to investigate the effect of fibrinogen concentrate on clinical outcomes.

Figure 1

EXTEM test results. Results from the extrinsically activated EXTEM assay, performed using ROTEM. Results were obtained at the following timepoints: upon emergency room (ER) admission, intensive care unit (ICU) admission and 24 hours after ER admission. Data are presented as median values; error bars represent interquartile ranges. CT, clotting time; CFT, clot formation time; MCF, maximum clot firmness. FC group, patients receiving fibrinogen concentrate only; FC–PCC group, patients receiving fibrinogen concentrate and prothrombin complex concentrate; FC–PCC–FFP group, patients receiving fibrinogen concentrate, prothrombin complex concentrate and fresh frozen plasma. *p < 0.05, ***p < 0.001, ns = not significant (unpaired t-test or Mann–Whitney U test).

Figure 2

Fibrinogen concentration and FIBTEM test results. For the fibrin-based FIBTEM assay, clot amplitude at 10 min running time (CA₁₀) is shown. Results were obtained at the following timepoints: upon admission to the emergency room (ER), upon admission to the intensive care unit (ICU) and approximately 24 hours (24h) after ER admission. Data are presented as median values with interquartile ranges; error bars represent minimum and maximum values. FIBTEM, extrinsically activated test of fibrin-based clotting (cytochalasin D inhibits platelet contribution to clot strength); CA₁₀, clot amplitude at 10 minutes. FC group, patients receiving fibrinogen concentrate only; FC–PCC group, patients receiving fibrinogen concentrate and prothrombin complex concentrate; FC–PCC–FFP group, patients receiving fibrinogen concentrate, prothrombin complex concentrate and fresh frozen plasma. *p < 0.05, **p < 0.01, ***p < 0.001, ns = not significant (unpaired t-test or Mann–Whitney U test).