Effects of serum fibrinogen correction on outcome of traumatic cranial surgery: A randomized, single-blind, placebo-controlled clinical trial

Background: Traumatic brain injury (TBI) is strongly associated with coagulopathy that occurs in 25-35% of patients. This complication is linked to higher mortality and morbidity. Recent lines of evidance have supported administration of fibrinogen concentrate (FC) in patients with severe TBI, while its efficacy remains contro-versial. In this study we aim to evaluate the effectiveness of serum fibrinogen level correction from 1.5 and 2.0 g/ l to more than 2.0 g/l in patients with severe TBI undergoing traumatic cranial surgery.Method: This randomized, single-blind, placebo-controlled clinical trial included trauma patients who had abbreviated injury scale (AIS) more than 3 in head and below 3 in other organs. FC was administered intrave-nously to patients with severe TBI undergoing TBI to correct the fibrinogen level above 2 g/l. Patients were randomly assigned to FC and control groups. The amount of intra-operative blood loss, packed cell (PC) trans-fusion, formation of new intracranial hemorrhage, and hemovac drainage were compared between the two study groups.Results: Forty-seven of 65 participants received the study intervention within 40-112 min of admission. Intra-operative PC transfusion was higher in FC group (80%) compared to control group (55.5%) while the differ-ance was not statistically significant (p > 0.05). Intra-operative blood loss was significantly higher in control group than FC group (P = 0.036). Chance of re-operation and new intracranial hematoma were not significantly different between two study groups.Conclusion: Early delivery of FC, decreases intraoperative bleeding. Although based on our findings it has no other effect on other parameters, further multicenter studies are recommended to investigate the role of early FC administration in management of post traumatic coagulopathy.

Automated summary

The effectiveness of correcting serum fibrinogen level in severe traumatic brain injury patients undergoing traumatic cranial surgery was evaluated in this study. Early delivery of fibrinogen concentrate (FC) was found to decrease intraoperative bleeding, but had no significant effect on other parameters. Further multicenter studies are recommended to investigate the role of early FC administration in the management of post traumatic coagulopathy.