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Trial record 11 of 422 for:    TRANEXAMIC ACID

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
Sponsor:
Collaborator:
Imprimis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mark Boiskin, California Institute of Renal Research

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

Condition or disease Intervention/treatment Phase
Arteriovenous Fistula Drug: Topical Tranexamic Acid 5% with bacitracin Other: Topical Tranexamic Acid 25% with bacitracin Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Local Infection [ Time Frame: 2 months ]
    After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
California Institute of Renal Research
Imprimis Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Mark Boiskin, MD California Institute of Renal Research

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Responsible Party: Mark Boiskin, MD, California Institute of Renal Research
ClinicalTrials.gov Identifier: NCT02106962     History of Changes
Other Study ID Numbers: 001-Boiskin
First Posted: April 8, 2014    Key Record Dates
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mark Boiskin, California Institute of Renal Research:
hemodialysis
fistula
clotting
tranexamic acid
bacitracin
Additional relevant MeSH terms:
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Tranexamic Acid
Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Bacitracin
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Bacterial Agents