Defibrination on treatment of acute cerebral infarction of internal carotid artery system:a prospectire randomized controlled trial

Objective To evaluate the efficacy and safety of the defibrinogenating agent Batroxobin for patients with acute cerebral infarction( ACI) of internal carotid artery system( ICAS) within 24 hours of ictus.Methods 150 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 divided into Batroxobin group ( n=75 ) and placebo group ( n=75 ).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 endpoinls.Results Mortality was not different between treatment groups (in 6 months, 4.0% for the Batroxobin group and 2.7% for the placebo group, P=1.00, RR=1.50, 95%CI: 0.26～8.72 ).The proportion of obvious dependent survival status and death or disability did not differ between patients given Batroxobin and those given placebo at 3 months ( 23.6% vs 38.4%, P=0.055, RR=0.49, 95%CI:0. 24～1.02 and 33.3% vs 46.7%, P=0.096, RR=0.57, 95%CI:0.29～ 1.11 ).In the 180th day after the therapy, the Batroxobin group showed a remarkable improvement in obvious dependent survival status and death or disability ( 16.7% vs 32.9%, P=0.024, RR=0.41, 95%CI: 0.19 ～ 0.89 and 24.0% vs 40.0%, P=0.022, RR=0.44,95%CI: 0.22 ～ 0.89 ).No symptomatic intracranial hemorrhages were observed in twogroups.There was a trend toward more extracranial hemorrhages in the Batroxobin group vs placebo group ( 16.0% vs 5.3%, P=.034, RR=3.00, 95%CI: 1.01～8.88 ). Conclusions This study showed that it appears safe and effective of defibrination on treatment of ACI of 1CAS within 24 hours of ictus. Key words: Batroxobin;  Cerebral infarction Internal carotid artery system;  Randomized controlled trial