NCT02106962

Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: California Institute of Renal Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 The clotting time will be compared to the clotting time at a different dialysis session in which no treatment will be used

Conditions

• Arteriovenous Fistula

Interventions

Type	Name	Description
DRUG	Topical Tranexamic Acid 5% with bacitracin	Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
OTHER	Topical Tranexamic Acid 25% with bacitracin	Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-04-08
• Last updated: 2017-09-25
• Results posted: 2017-09-25

Locations

3 sites across 1 country: United States