Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

Arteriovenous Fistula Clinical Trial

Official title:

The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106962
• Other study ID #: 001-Boiskin
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2014
• Last updated: August 25, 2017
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2017
• Source: California Institute of Renal Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

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.

Locations

Country	Name	City	State
United States	California Insitute of Renal Research	San Diego	California
United States	Fresenious Medical Care - Rancho	San Diego	California
United States	Fresenius Medical Care - Kearny Mesa	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
California Institute of Renal Research	Imprimis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local Infection	After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study	2 months