Fibrinogenase Injection Improves Functional Outcome Following Ischemic Stroke

In a late-breaking presentation at the 2024 International Stroke Conference (ISC), held February 7-9, in Phoenix, Arizona, findings from a randomized, placebo-controlled study revealed that treatment with fibrinogenase injection within 72 hours after acute ischemic stroke (AIS) resulted in better functional outcomes to that of the control group.¹

Presented by Xin Jiang, department of neurology, Sichuan University, China, the double-blind study featured 235 patients with AIS who were randomly assigned 1:1 to either 7-day fibrinogenase for injection (n = 118) or placebo (n = 117). Patients included in the study were between 18 to 85 years of age, with a National Institute of Health Stroke Scale (NIHSS) score between 4 and 25. The primary end point was the modified Rankin Scale (mRS) score at 3 months post-randomization.

At 90 days post-randomization, results showed a significantly lower functional outcome on mRS scale for the fibrinogenase group than those on placebo (P <.001). In addition, functional outcomes were more favorable on day 90 (mRS score ≤2 86.73% vs 72.73%; OR, 2.11; 95% CI 1.10-4.03; P = .496). Between the 2 groups, the rate of bleeding and death events were not statistically significant (P = .627; P = .496).

In stroke, inflammation is a risk factor of atherosclerosis and during ischemic events. Many inflammatory markers as fibrinogen and high sensitive C-reactive protein have been reported as predictable markers for stroke severity and outcome. Fibrinogen is also considered a major determinant of whole blood and plasma viscosity. Elevated levels have been associated with atherosclerosis and coronary heart disease, peripheral vascular disease, and carotid stenosis.

A 2020 study published in The Egyptian Journal of Critical Care Medicine aimed to estimate fibrinogen levels in patients with ischemic stroke in a medical intensive care unit (ICU) and their relationship to other risk factors and outcome. The observational cohort study featured 64 ICU patients with either AIS (n = 32) or non-AIS (n = 32). All told, a significant increase in serum fibrinogen levels was noticed in those with AIS (P <.001). When using a cutoff value of greater than 439 mg/dL, investigators observed a sensitivity of 92.31%, specificity of 75.36%, and accuracy of 84.34% for stroke occurrence with area under the curve (AUC) of 93.75%.²

Additional findings from that study showed a sensitivity of 85.71%, specificity of 96%, and accuracy of 93.75% for mortality when using a cutoff value of at least 557 mg/dL (AUC, 0.97). Only diabetes mellitus demonstrated an impact on the in-hospital outcome (P = .04). Regarding the relation between fibrinogen level and in-hospital outcome, the study showed that 7 patients (21.9%) died within 15 days of admission with fibrinogen levels greater than 557 mg and an APACHE II score between 11 and 18.