Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

California Institute of Renal Research

Status and phase: Completed; Phase 4

Conditions: Arteriovenous Fistula

Treatments: Drug: Topical Tranexamic Acid 5% with bacitracin; Other: Topical Tranexamic Acid 25% with bacitracin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02106962

001-Boiskin

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dialysis patients with fistulas (native arterio-venous)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

Clotting time Using Tranexamic Acid 5%

Experimental group

Description:

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

Treatment:

Drug: Topical Tranexamic Acid 5% with bacitracin

Clotting Time Using Tranexamic Acid 25%

Experimental group

Description:

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

Treatment:

Other: Topical Tranexamic Acid 25% with bacitracin