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临床试验/EUCTR2007-007157-31-SE
EUCTR2007-007157-31-SE进行中(未招募)1 期

FIBRINOGEN AND BLEEDING AFTER CARDIAC SURGERY

Sahlgrenska Universitetssjukhuset0 个研究点目标入组 60 人开始时间: 2008年2月22日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
60

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

  • Males and females; age 18 years and above
  • Patients eligible for a first-time coronary artery bypass graft (CABG) surgery with a preoperative fibrinogen plasma concentration < 3.7 g/L.
  • Signed informed consent to participate in the study
  • 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

  • Patients undergoing reoperation
  • Clinical or laboratory signs of known bleeding disorder,
  • Clinical or laboratory signs of significant liver disease, or other significant disease or condition which in the investigators judgment may interfere with hemostasis
  • Any medication with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel och warfarin are withdrawn at least five days before surgery. Heparin and low-molecular heparin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.
  • Administration of other investigational drugs within eight weeks preceding the pre-entry examination
  • Pregnant or lactating women

研究者

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