Among patients with severe isolated head injury and acute posttraumatic hypofibrinogenemia, treatment with fibrinogen led to a higher Glasgow coma scale (GCS) score, better 90-day Glasgow outcome scale-extended (GOSE) scores, and regulated hematoma size within 3 days posttrauma. These are the findings of a study published in the Journal of Clinical Neuroscience.
Fibrinogen is key to coagulation. While coagulopathy is infrequent, in severe head injury the occurrence is over 60%, thus reducing fibrinogen (hypofibrinogenemia), a robust predictor for unfavorable neurologic outcome among these patients. Researchers sought to investigate neurologic outcomes among patients with severe TBI and concurrent hypofibrinogenemia treated with fibrinogen.
They conducted a single-blind, multi-center, randomized clinical trial (ClinicalTrials.gov Identifier: NCT03304899) from January 2019 to April 2021 in Al-Zahra and Kashani university hospital referral centers, Isfahan, Iran that included 137 patients with severe TBI (GSC score <9), of whom 5 were excluded, 20 refused to participate, and 8 were dropped for other reasons. Most agencies define hypofibrinogenemia as severe (fibrinogen <50 mg/dL), marked (50-100 mg/dL), moderate (100-150 mg/dL), mild (150-200 mg/dL and often not of concern).
In this study, patients with <200 mg/dL were randomly included in the fibrinogen receiving group (n=50), and the control group (n=54) with no concurrent coagulopathy. Among the fibrinogen receiving group, 1 patient refused to participate, 9 were lost to follow-up, 2 discontinued intervention, and 2 were excluded from analysis due to missing data (n=36; 9 female). After similar losses in the control group (n=35; 8 female), researchers report 71 patients were analyzed.
After 24, 48, and 72 hours, compared to the control group, the fibrinogen receiving group ‘sGCS scores were higher (P =0.0), hematoma was better controlled (P =0.0), and GOSE was also better (P =.25). Hospital stay duration, mechanical ventilator dependency, cranial surgery, in-hospital and 90-day post discharge mortality rates were similar between groups.
Study limitations include underpowered sample, lack of sophistication in the fibrinogen assay, selection bias, and possible nonresponse bias.
Researchers concluded that, “In severe traumatic brain injury, hypofibrinogenemia correction (>200 mg/dL) could improve GOSE, GCS score progression within 3 days after primary head injury and hematoma expansion controllability.”
Sabouri M, Vahidian M, Sourani A, Mahdavi SB, Tehrani DS, Shafiei E. Efficacy and safety of fibrinogen administration in acute post-traumatic hypofibrinogenemia in isolated severe traumatic brain injury: A randomized clinical trial. J Clin Neurosci. Published online May 26, 2022. doi:10.1016/j.jocn.2022.05.016