Incidence of ROTEM®-defined coagulopathy at hospital arrival among polytrauma patients receiving fibrinogen concentrate in prehospital setting: a prospective observational study.

PURPOSE: Trauma-induced coagulopathy affects approximately one-quarter of polytrauma patients and is associated with increased mortality. Given the central role of fibrinogen and its early depletion after injury, supplementation is recommended after hospital admission in the presence of hypofibrinogenaemia or suspected major haemorrhage. As coagulopathy develops within minutes of trauma, prehospital fibrinogen administration may help mitigate its progression before hospital arrival. This study evaluated the incidence of coagulopathy at hospital admission, assessed using ROTEM®, among polytrauma patients receiving fibrinogen concentrate in the prehospital setting.

METHODS

In this single-centre, prospective observational study, adult patients with polytrauma (Injury Severity Score ≥ 16) were enrolled after prehospital administration of fibrinogen concentrate. The primary outcome was the presence of coagulopathy at hospital arrival, defined according to predefined ROTEM® Delta thresholds (FIBTEM MCF ≤ 8 mm and/or EXTEM CT ≥ 80 s and/or EXTEM MCF ≤ 49 mm). The secondary outcomes were laboratory coagulation status, 28-day all-cause mortality, and thromboembolic complications.

RESULTS

Thirty patients were enrolled, of whom 28 were included in the final analysis. Twenty-seven patients received 4 g of fibrinogen concentrate and one received 2 g due to short transport time. ROTEM®-defined coagulopathy was identified in two patients (7.1%), both based on EXTEM abnormalities; no patient had reduced FIBTEM MCF. Five patients (17.9%) died within 28 days and two patients (7.1%) experienced thromboembolic complications.

CONCLUSIONS

Our findings describe a low incidence of ROTEM®-defined coagulopathy at hospital arrival in polytrauma patients who received prehospital fibrinogen concentrate. Adequately powered randomized controlled trials are required to determine whether prehospital fibrinogen administration reduces coagulopathy and improves clinically relevant outcomes. TRIAL REGISTRATION: NCT03572309, ClinicalTrials.gov, registered on 19 June 2018.