Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
Primary Purpose
Arteriovenous Fistula
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Topical Tranexamic Acid 5% with bacitracin
Topical Tranexamic Acid 25% with bacitracin
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula focused on measuring hemodialysis, fistula, clotting, tranexamic acid, bacitracin
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.
Sites / Locations
- Fresenius Medical Care - Kearny Mesa
- California Insitute of Renal Research
- Fresenious Medical Care - Rancho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Clotting time Using Tranexamic Acid 5%
Clotting Time Using Tranexamic Acid 25%
Arm Description
Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis
Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Local Infection
After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
Full Information
NCT ID
NCT02106962
First Posted
April 4, 2014
Last Updated
August 25, 2017
Sponsor
California Institute of Renal Research
Collaborators
Imprimis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02106962
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Institute of Renal Research
Collaborators
Imprimis Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula
Keywords
hemodialysis, fistula, clotting, tranexamic acid, bacitracin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clotting time Using Tranexamic Acid 5%
Arm Type
Experimental
Arm Description
Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis
Arm Title
Clotting Time Using Tranexamic Acid 25%
Arm Type
Experimental
Arm Description
Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis
Intervention Type
Drug
Intervention Name(s)
Topical Tranexamic Acid 5% with bacitracin
Other Intervention Name(s)
Cyklokapron
Intervention Description
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
Other
Intervention Name(s)
Topical Tranexamic Acid 25% with bacitracin
Other Intervention Name(s)
Cyklokapron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clotting TIme
Description
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
Time Frame
13 minutes
Secondary Outcome Measure Information:
Title
Local Infection
Description
After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Boiskin, MD
Organizational Affiliation
California Institute of Renal Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresenius Medical Care - Kearny Mesa
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
California Insitute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Fresenious Medical Care - Rancho
City
San Diego
State/Province
California
ZIP/Postal Code
92127
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
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