A Randomized Controlled Trial of Effect of Defibrination on Treatment of Acute Cerebral Infarction of Internal Carotid Artery System

Objective To evaluate the efficacy and safety of the defibrinogenating agent Batroxobin in patients with acute cerebral infarction(ACI) of internal carotid arterial system(ICAS) within 24 hours of ictus.Methods 100 patients with ACI of ICAS within 24 hours of ictus were included in this randomized placebo-controlled trial.Brain CT scans were done to exclude intracranial haemorrhages.Patients were randomly assigned to receive Batroxobin group(n=50) and placebo group(n=50).The primary outcome was the death rate,obvious dependent survival status(Barthel Index≤60) and disability(modified Rankin Scale≥3) at the third month and sixth month.The National Institutes of Health Stroke Scale was used as secondary endpoints.Results Mortality was not different between treatment groups(in 6 months,4.0% for the batroxobin group and 2.0% for the placebo group;P=1.00 RR=2.00,95% CI:0.19 to 21.36).The proportion of obvious dependent survival status did not differ between patients given batroxobin and those given placebo at 3 months(22.9% vs 34.7% P=0.201,RR=0.66,95% CI:0.35 to 1.26)and at 6 months(20.8% vs 32.7%,P=0.189,RR=0.64,95% CI: 0.32 to 1.26).The proportion of death or disability did not differ in the Batroxobin group and the placebo group at 3 months(34.0% vs 46.0% P=0.221,RR=0.74,95%CI: 0.45 to 1.21)and at 6 months(28.0% vs 40.0%,P=0.205,RR=0.70,95%CI:0.40 to 1.23).No symptomatic intracranial hemorrhages were observed in two groups.There was a trend toward more extracranial hemorrhages in the Batroxobin group vs placebo group(22.0% vs 6.0%,P=0.021),RR=3.67,95% CI: 1.09 to 12.36).Conclusion Batroxobin appears safe and effective in degrading plasma FIB.At the same time,this study did not show that clinical efficacy of batroxobin was superior to placebo for ACI of ICAS within 24 hours of ictus,but we need a large sample,randomized and control study to confirm.