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临床试验/NCT02106962
NCT02106962已完成4 期

The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

California Institute of Renal Research3 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
17
试验地点
3
主要终点
Clotting TIme

研究概览

简要总结

This study will investigate how the use of Tranexamic acid and Bacitracin applied to the bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and Infection Rate

详细描述

Visit 1 - Initial Application:

  • A patient candidate identified by the PI who meets all of the inclusion criteria and none of the exclusion criteria will be consented for the study.
  • The medical history will be collected from the subject.
  • The subject will receive routine hemodialysis
  • Directly after the completion of hemodialysis, the following study drug application steps will occur:
  1. Site 1 Initial Compression: Apply fixed amount of Tranexamic acid and bacitracin 5% or 25% to gauze and compress for 3 minutes to needle site 1.
  2. Site 2 Initial Compression: Apply fixed amount of Tranexamic acid and bacitracin 5% or 25% to gauze and compress for 3 minutes to needle site 2.
  3. Second Compression per site: If bleeding has not stopped, repeat application with new gauze and same amount of ointment to each respective site and compress for 5 minutes more at each site.
  4. Third Compression per site: If after the second application and compression the bleeding persists repeat both application and compression for another 5 minutes (total time would be 13 minutes at this step).
  5. Test Failure: If after the third application to each needle site there is still bleeding, the testing would be considered a failure and routine procedures should be utilized to stop the bleeding.
  • Any adverse events will be collected.

Visit 2 - Follow-Up:

• The 1 week follow up visit will be performed to review study drug application site and to collect any adverse events reported by subject

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Dialysis patients with fistulas (native arterio-venous)

排除标准

  • Previous sensitivity to or adverse reaction to Tranexamic acid or Bacitracin.
  • Active infection.
  • Stenosis of fistula.

研究组 & 干预措施

Clotting time Using Tranexamic Acid 5%

Experimental

Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis

干预措施: Topical Tranexamic Acid 5% with bacitracin (Drug)

Clotting Time Using Tranexamic Acid 25%

Experimental

Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis

干预措施: Topical Tranexamic Acid 25% with bacitracin (Other)

结局指标

主要结局

Clotting TIme

时间窗: 13 minutes

After completing dialysis, the clotting time of the arteriovenous fistula of each participant was measured, using either Tranexamic Acid 5% or Tranexamic Acid 25% and compared to the regular clotting time of the AV Fistula without using the Tranexamic Acid

次要结局

  • Local Infection(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Boiskin

MD

California Institute of Renal Research

研究点 (3)

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