Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

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

Study Overview

• Status: Completed
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Drug: Topical Tranexamic Acid 5% with bacitracin; Other: Topical Tranexamic Acid 25% with bacitracin

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92111
      • Fresenius Medical Care - Kearny Mesa
    • San Diego, California, United States, 92123
      • California Insitute of Renal Research
    • San Diego, California, United States, 92127
      • Fresenious Medical Care - Rancho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 Names: Cyklokapron
Experimental: 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	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.; Other Names: Cyklokapron

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: California Institute of Renal Research
• Collaborators: Imprimis Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Mark Boiskin, MD, California Institute of Renal Research

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: hemodialysis; tranexamic acid; fistula; clotting; bacitracin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Fibrin Modulating Agents; Anti-Bacterial Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid; Bacitracin
• Other Study ID Numbers: 001-Boiskin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No