Defibrinogen Therapy for Acute Ischemic Stroke: 1332 Consecutive Cases.

This study aimed to examine the effectiveness of defibrinogen therapy on functional recovery and safety among 1332 consecutive ischemic stroke patients who had not received intravenous thrombolysis with recombinant tissue plasminogen activator. Stroke patients undergoing conservative and relatively individualized multiple-day dosing regimens of defibrinogen therapy between January 1, 2008 and May 30, 2016 were enrolled. Data were analyzed according to functional success (Barthel Index of 95 or 100, mRS of 0 or 1) and safety variables (intracranial hemorrhage, mortality and stroke recurrence). At 12 months, 18.62% (203/1087) of patients were lost to follow-up. The functional success rates were 39.84% (526/1320) and 42.23% (459/1087) as assessed by BI at 3 months and 12 months, respectively. Fifteen patients had asymptomatic intracranial hemorrhage within 24 hours after the initial defibrase administration. During the 14 days after hospitalization, 12 patients were diagnosed with symptomatic intracranial hemorrhage (sICH) and a total of 12 patients died from all causes. At 3 months, 56 patients were dead and 21 patients had recurrent stroke. The percentage of death and recurrence of stroke at 12 months were 6.81% and 3.22%, respectively. Results from the historical control showed no significant differences of functional success were detected between the patients treated with rt-PA within 6 hours of stroke onset in NINDS II and the patients treated with defibrase within 6 hours after stroke in the present study. The multiple-day dosing regimen of defibrinogen therapy using defibrase applied in the present study could achieve functional improvement among acute ischemic stroke patients, with low risks of mortality when compared with other similar studies. However, the efficacy and safety of such a defibrinogenating therapy is needed to be verified by RCTs with large sample size.