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临床试验/EUCTR2012-005407-40-DK
EUCTR2012-005407-40-DK进行中(未招募)1 期

Peroperative Tranexamic acid as prophylaxis of bleeding related to benign hysterectomy - a randomized, placebo-controlled trial - PeTraH-studiet

Thomas Bergholt0 个研究点目标入组 314 人开始时间: 2013年1月9日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
314

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
Female

入选标准

  • All women above 18 years of age to undergo elective benign hysterectomy during the study period should be invited to participate.
  • 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 214
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Known thrombophilia
  • Active / previous thromboembolic disease
  • Family history to thromboembolic disease (thrombophilia in the family)
  • Hypersensitivity to Tranexamic acid
  • Impaired renal function
  • Ongoing hematuria
  • Subarachnoid hemorrhage
  • Daily use of anticoagulant medication
  • Preoperative use of Tranexamic acid within 24 hours before surgery
  • Known malignancy or hysterectomy as part of the investigation of suspected malignancy
  • Insufficient understanding of the information concerning the project

研究者

发起方
Thomas Bergholt

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