Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT02106962|
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula||Drug: Topical Tranexamic Acid 5% with bacitracin Other: Topical Tranexamic Acid 25% with bacitracin||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: 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
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 Name: Cyklokapron
Experimental: 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
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.
Other Name: Cyklokapron
- 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
- Local Infection [ Time Frame: 2 months ]After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106962
|United States, California|
|Fresenius Medical Care - Kearny Mesa|
|San Diego, California, United States, 92111|
|California Insitute of Renal Research|
|San Diego, California, United States, 92123|
|Fresenious Medical Care - Rancho|
|San Diego, California, United States, 92127|
|Principal Investigator:||Mark Boiskin, MD||California Institute of Renal Research|