Fibrinogenase Injection Improves Functional Outcome Following Ischemic Stroke

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Over a 90-day period, investigators observed significantly lower functional outcomes on modified Rankin Scale and similar rates of bleeding and death when compared with control.

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.

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REFERENCES
1. Fang J, Ma Mengmeng, Zhang Y, He L, Jiang X. Fibrinogenase for injection in the treatment of acute ischemic stroke: a randomized double blind and placebo controlled study. Presented at: international Stroke Conference; February 7-9, 2024; Phoenix, AZ. LB11
2. Samir G, Khalil O, Fawzy M, Sadek A. Study of fibrinogen level in acute ischemic stroke patients in medical intensive care unit. Egyptian Journal of Critical Care Medicine. 2020;7(2-3):51-56. doi:10.1097/EJ9.0000000000000009