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:
相关药物
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
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