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NCT Number: NCT02106962

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

California Insitute of Renal Research, San Diego, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical Tranexamic Acid 5% with bacitracin

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.

Other names: Cyklokapron

Topical Tranexamic Acid 25% with bacitracin

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.

Other names: Cyklokapron

Primary outcomes

  1. Clotting TIme

    Time frame: 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 outcomes

  1. Local Infection

    Time frame: 2 months

    After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study

Sponsors and collaborators

Lead sponsor

California Institute of Renal Research

Other

Collaborators

  • Imprimis Pharmaceuticals, Inc.

Registry information

Official study title

The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2014
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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