Background Severe deficiency in human fibrinogen is a cause of massive haemorrhage whose management in emergency situations is the subject of debate.

Purpose A prospective, observational study to ascertain how human fibrinogen is used in patients with life-threatening haemorrhagic disorders (trauma and surgery), especially in patients with underlying disease states that limit fibrinogen synthesis. Moreover, it aims to assess the adherence to the European guideline recommendations.

Materials and methods In a third-level hospital, patients with a documented life-threatening haemorrhage who received a human fibrinogen prescription were included in the protocol, over a period of 12 months. Demographic data, treatment indication, prothrombin time, plasma fibrinogen, haemoglobin and haematocrit before and after treatment; admission diagnosis, fibrinogen dose and concomitant blood product treatment were collected.

Results 46 patients were treated with human fibrinogen and included in the analysis. Patients’ mean age was 55.23 (18–85) years, 30.43% were women and 69.57% men. The average dose was 2.39 g, the global survival after seven days was 86.96% and 34.78% had concomitant treatment with prothrombin complex concentrates (PCC).

80.43% of patients underwent surgery and 82.61% suffered an active haemorrhage. The mean initial fibrinogen level was 1.77 g/L, and post-administration the mean level increased to 2.43 g/L. The fibrinogen biological recovery was 105%. 58.63% of patients had initial fibrinogen levels beneath 2 g/L, while the other 41.38% didn’t meet the clinical guideline recommendations.

Quick time (s) (% t/ INR):

• – Before administration: 21.73s (68.88%, 1.62)

• – After administration: 19.20s, (75.96%, 1.38)

• – After three days: 18.38s (79.96%, 1.36)

• – After seven days: 17.35s (84.71%, 1.29)

Haemoglobin (g/dL) and haematocrit (%) levels:

• – Before administration: 9.37g/dL/27.46%

• – After administration: 9.63 g/dL/28.02%

• – After three days: 9.77 g/dL/28.44%

Regarding to the European Clinical Guidelines, 41.38% of the treatments did not follow their recommendations as the initial fibrinogen levels were superior to 2 g/L.

Conclusions Following fibrinogen administration a great improvement in the coagulation parameters was observed, as well as in the haemoglobin and haematocrit levels. Finally, the European Clinical Guidelines were not followed in a significant percentage as fibrinogen was administered in spite of initial fibrinogen levels greater than 2 g/L.

No conflict of interest.