[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of recombinant batroxobin in hemostatic treatment in subjects undergoing posterior cervical spine surgery and posterior lumbar interbody fusion
主要目的:
?评估重组巴曲酶与安慰剂对比在颈椎后路手术与腰椎后路椎间融合术受试者止血治疗的疗效;
次要目的:
评估重组巴曲酶与安慰剂对比在颈椎后路手术与腰椎后路椎间融合术受试者止血治疗的疗效、安全性以及免疫原性。
[Translation] Primary purpose:
? To evaluate the efficacy of recombinant batroxobin compared with placebo in hemostatic treatment of subjects undergoing posterior cervical spine surgery and posterior lumbar interbody fusion;
Secondary purpose:
To evaluate the efficacy, safety and immunogenicity of recombinant batroxobin compared with placebo in hemostatic treatment of subjects undergoing posterior cervical spine surgery and posterior lumbar interbody fusion.