The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
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:
- 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.
- 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.
- 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.
- 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).
- 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
- 否
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%
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%
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
Mark Boiskin
MD
California Institute of Renal Research
