Pre-emptive administration of fibrinogen concentrate contributes to improved prognosis in patients with severe trauma

Abstract

Background: Patients with severe trauma often present with critical coagulopathy, resulting in impaired hemostasis, massive hemorrhage, and a poor survival prognosis. The efficacy of hemostatic resuscitation in correcting coagulopathy and restoring tissue perfusion has not been studied. We assessed a novel approach of pre-emptive administration of fibrinogen concentrate to improve critical coagulopathy in patients with severe trauma.

Methods: We retrospectively compared blood transfusion volumes and survival prognosis between three groups of patients with trauma, with an Injury Severity Score (ISS) ≥26 over three consecutive periods: group A, no administration of fibrinogen concentrate; group B, administration of 3 g of fibrinogen concentrate after evaluation of trauma severity and a plasma fibrinogen level <1.5 g/L; group C, pre-emptive administration of 3 g of fibrinogen concentrate immediately on patient arrival based on prehospital information, including high-severity injury or assessed need for massive transfusion before measurement of fibrinogen.

Results: ∼56% of patients with an ISS ≥26 and transfused with red blood cell concentrates ≥10 units, had hypofibrinogenemia (fibrinogen <1.5 g/L) on arrival. Patients who received fibrinogen concentrate in group C showed significantly higher fibrinogen levels after treatment with this agent than those in group B (2.41 g/L vs 1.88 g/L; p=0.01). Although no significant difference was observed in blood transfusion volumes between the groups, the 30-day survival of patients in group C (all, and those with an ISS ≥26) was significantly better than in group A (p<0.05). The 48-hour mortality rate in patients with an ISS ≥26 was significantly lower in group C than in group A (8.6% vs 22.9%; p=0.005). Further, among patients with an ISS ≥41, the overall mortality was significantly lower in group C than in group A (20% vs 50%; p=0.02).

Conclusion: Pre-emptive administration of fibrinogen concentrate for patients with trauma with critical coagulopathy may contribute to improved survival.

Level of evidence: Level IV.

Keywords: coagulopathy; hemorrhage; hemostasis; transfusion.

Figure 1

The proportion of patients with hypofibrinogenemia. (A) The percentage of each category of fibrinogen level on arrival in trauma patients with ISS ≥26 and transfused with red blood cell concentrates (RBC) ≥10 units (group A, n=56; group B, n=60; and group C, n=64). Fibrinogen concentration in plasma: black portions, <1.0 g/L; hatched portions, 1.0–1.5 g/L; white portions, >1.5 g/L. (B) The fibrinogen levels in patients before and after administration of fibrinogen concentrate in group B (hatched columns; n=30) and C (black columns; n=35). The data are presented as the mean and SD. Differences between groups B and C were evaluated using the unpaired t-test (*p=0.01). ISS, Injury Severity Score.

Figure 2

The 30-day survival curves were analyzed in all patients (left panel) and in patients with an ISS ≥26 (right panel), excluding patients with cardiopulmonary arrest, in all three groups using Gehan-Breslow-Wilcoxon tests and the Kaplan-Meier method. Significant differences (*p<0.05) were detected in both analyses between group A (n=441 in total and 75 with an ISS ≥26) and group C (n=536 in total and 101 with an ISS ≥26). ISS, Injury Severity Score.

Figure 3

Mortality of trauma patients with high severity. Left panel: The mortality within 48 hours of arrival at the hospital for patients with an ISS ≥26 in groups A to C (n=105 for group A; n=114 for group B; n=128 for group C). A significant difference was detected between group A and C (p=0.005) after evaluation by Pearson's χ² test. Right panel: The overall mortality of patients with an ISS ≥41 in groups A to C (n=30 for group A; n=22 for group B; n=25 for group C). A significant difference was detected between group A and C (p=0.02) after evaluation by Pearson's χ² test. White columns, group A; hatched columns, group B; black columns, group C. ISS, Injury Severity Score.