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临床试验/NCT01221909
NCT01221909Unknown不适用

Single Dose Tranexamic Acid for Dacryocystorhinostomy

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.

研究概览

简要总结

Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study.

The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • obstruction of nasolacrimal pathway
  • eligible for DCR surgery
  • 18 years of age or older

排除标准

  • warfarin treatment
  • renal insufficiency
  • pregnancy
  • mental retardation
  • tendency to bleed
  • thromboembolic disease
  • thrombophilia

研究组 & 干预措施

Tranexamic acid single dose of 500mg

Experimental

干预措施: Tranexamic acid (Drug)

Saline

Placebo Comparator

干预措施: saline solution (Drug)

结局指标

主要结局

Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery.

时间窗: Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end.

次要结局

  • Late onset postoperative epistaxis or periorbital hematoma(8 days)

研究者

申办方类型
Other

研究点 (1)

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