Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

NCT ID: NCT02106962

Last Updated: 2017-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-08-31

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

Conditions

Arteriovenous Fistula

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Topical Tranexamic Acid 5% with bacitracin

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Topical Tranexamic Acid 25% with bacitracin

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Cyklokapron; Cyklokapron

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imprimis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

California Institute of Renal Research

OTHER

Sponsor Role: lead

Responsible Party

Mark Boiskin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Boiskin, MD

Role: PRINCIPAL_INVESTIGATOR

California Institute of Renal Research

Locations

Fresenius Medical Care - Kearny Mesa

San Diego, California, United States

California Insitute of Renal Research

San Diego, California, United States

Fresenious Medical Care - Rancho

San Diego, California, United States

Countries

United States

Other Identifiers

001-Boiskin

Identifier Type: -

Identifier Source: org_study_id