Clinical trial NCT02106962: Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
Official title: The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arteriovenous Fistula
Keywords: hemodialysis
fistula
clotting
tranexamic acid
bacitracin
Lead sponsor: California Institute of Renal Research
Sponsor class: OTHER
Collaborators: name: Imprimis Pharmaceuticals, Inc.
First posted: 2014-04-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Clotting TIme
timeFrame: 13 minutes
Secondary outcomes:
measure: Local Infection
timeFrame: 2 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Fresenius Medical Care - Kearny Mesa
state: California
city: San Diego
country: United States
facility: California Insitute of Renal Research
state: California
city: San Diego
country: United States
facility: Fresenious Medical Care - Rancho
state: California
Study officials:
affiliation: California Institute of Renal Research
name: Mark Boiskin, MD
role: PRINCIPAL_INVESTIGATOR
References: