跳至主要内容
临床试验/EUCTR2005-001228-35-GB
EUCTR2005-001228-35-GB进行中(未招募)不适用

A randomized, single-blind, parallel-group, multi-center comparative study to assess the efficacy and safety of an application of Fybex (fibrin sealant) to the operative field, for the reduction of post-operative blood loss, when added to standard intra-operative hemostatic procedures and compared to standard intra-operative hemostatic procedures alone, in adult patients undergoing total hip arthroplasty - A study to assess the effect of Fybex fibrin sealant on post-operative blood loss, given during hip

Bio Products Laboratory0 个研究点目标入组 90 人开始时间: 2005年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • ·Patients undergoing total hip replacement·Age > 18 years·Able to give informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • ·History of bleeding disorders·Hb < 110g/L·Previous hip surgery·Use of other blood products within 3 months·Positive for HBsAg, HCV or HIV

研究者

发起方
Bio Products Laboratory

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