Early administration of fibrinogen concentrates improves the short-term outcomes of severe pelvic fracture patients

Abstract

Aim: Hemorrhage from pelvic fracture is a major cause of mortality after blunt trauma. Several studies have suggested that early fibrinogen supplementation improves outcomes of traumatic hemorrhage. Thus, we revised our massive transfusion protocol (MTP) in April 2013 to include early off-label administration of fibrinogen concentrate. The objective of this study was to evaluate the impact of the revision on the short-term outcomes of pelvic fracture patients.

Methods: This was a single-center, retrospective, cohort study. A total of 224 consecutive pelvic fracture patients hospitalized in Saitama Medical Center (Saitama, Japan), 115 before the revision (Group E) and 109 after (Group L), were enrolled. Characteristics of the patients were compared between the groups. Impacts of the revision were evaluated by hazard ratios adjusted for characteristics, injury severity, and coagulation status using Cox's multivariate proportional hazard model. The impact was also evaluated by log-rank test and relative risk of 28-day mortality between the groups.

Results: The characteristics were equivalent between the groups. The multivariate analysis revealed that the revision of MTP was significantly related to improved survival with an adjusted hazard ratio (95% confidence interval) of 0.45 (0.07-0.97). The log-rank test gave χ²-test values of 5.2 (P = 0.022) and 6.7 (P = 0.009), and the relative risks were 0.37 (0.15-0.91) and 0.33 (0.13-0.84), in patients with all Injury Severity Scores and Injury Severity Score ≥21, respectively.

Conclusion: The revision of MTP to include aggressive off-label treatment with fibrinogen concentrate was related to improved short-term outcomes of severe pelvic fracture patients. However, due to the limitations of the study, the improvement could not be attributed totally to the revision.

Keywords: Blood coagulation disorders; fibrinogen; hemorrhage; pelvic bones; trauma.

Figure 1

Flow chart to describe the institutional massive transfusion protocol (MTP) for trauma patients. The MTP was revised in April 2013 to include early administration of fibrinogen concentrate. APTT, activated partial thrombin time; PT, prothrombin time.

Figure 2

Twenty‐eight‐day survival curves of pelvic fracture patients compared between the treatment groups. Broken lines represent the curve of Group E (those hospitalized before April 2013, before the revision of the institution's massive transfusion protocol) and solid lines represent that of Group L (those hospitalized in April 2013 and later, when the massive transfusion protocol included early off‐label administration of fibrinogen concentrate). The curves of the patients with all Injury Severity Scores (ISS) (top), and those of patients with ISS ≥ 21 (bottom) are shown.