Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

Phase 4

Completed

Conditions: Arteriovenous Fistula

Interventions: Drug: Topical Tranexamic Acid 5% with bacitracin
Other: Topical Tranexamic Acid 25% with bacitracin

Registration Number: NCT02106962

Lead Sponsor: California Institute of Renal Research

Brief 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clotting time Using Tranexamic Acid 5%	Topical Tranexamic Acid 5% with bacitracin	Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis
Clotting Time Using Tranexamic Acid 25%	Topical Tranexamic Acid 25% with bacitracin	Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis

Primary Outcome Measures

Name	Time	Method
Clotting TIme	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

Secondary Outcome Measures

Name	Time	Method
Local Infection	2 months	After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study

Trial Locations

Locations (3): Fresenius Medical Care - Kearny Mesa
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San Diego, California, United States
California Insitute of Renal Research
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San Diego, California, United States
Fresenious Medical Care - Rancho
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San Diego, California, United States