Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

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

Official Title
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The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Drug: Topical Tranexamic Acid 5% with bacitracin
* Other: Topical Tranexamic Acid 25% with bacitracin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clotting time Using Tranexamic Acid 5%<br>Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis | Drug: Topical Tranexamic Acid 5% with bacitracin<br>* 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.<br>* Other names: Cyklokapron;|
| Experimental: Clotting Time Using Tranexamic Acid 25%<br>Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis | Other: Topical Tranexamic Acid 25% with bacitracin<br>* 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.<br>* Other names: Cyklokapron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clotting TIme | 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 | 13 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Infection | After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fistula, hemodialysis, clotting, tranexamic acid, bacitracin