Arteriovenous FistulaPhase 4NCT02106962
Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
A Phase 4 study testing Topical Tranexamic Acid 5% with bacitracin and Topical Tranexamic Acid 25% with bacitracin in people with Arteriovenous Fistula, run by California Institute of Renal Research at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Topical Tranexamic Acid 5% with bacitracin and Topical Tranexamic Acid 25% with bacitracin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis patients with fistulas (native arterio-venous)
Who cannot join
- Previous sensitivity to or adverse reaction to Tranexamic acid or Bacitracin.
- Active infection.
- Stenosis of fistula.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fresenius Medical Care - Kearny Mesa
San Diego, California, 92111
California Insitute of Renal Research
San Diego, California, 92123
Fresenious Medical Care - Rancho
San Diego, California, 92127
About this study
Official title: The 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
Read the 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
- Conditions
- Arteriovenous Fistula
- Being tested
- Topical Tranexamic Acid 5% with bacitracin, Topical Tranexamic Acid 25% with bacitracin
- Keywords
- hemodialysis, fistula, clotting, tranexamic acid, bacitracin
- Medical subject headings
- Arteriovenous Fistula, Fistula, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Tranexamic Acid 5% with bacitracinDrug
Also called Cyklokapron
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.
Topical Tranexamic Acid 25% with bacitracinOther
Also called Cyklokapron
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.
| Study group | Role | What they receive |
|---|---|---|
| Clotting time Using Tranexamic Acid 5% | Experimental | Measure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis Receives: Drug: Topical Tranexamic Acid 5% with bacitracin |
| Clotting Time Using Tranexamic Acid 25% | Experimental | Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis Receives: Other: Topical Tranexamic Acid 25% with bacitracin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 minutes
Secondary outcomes (1)
Local Infection
After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Institute of Renal Research
- Sponsor type
- University, hospital or other
- Collaborators
- Imprimis Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Mark Boiskin, California Institute of Renal Research
- Investigators
- Mark Boiskin, MD, Principal investigator, California Institute of Renal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106962
- Sponsor's protocol ID
- 001-Boiskin
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2014
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
- ClinicalTrials.gov ID
- NCT02106962
- Acronym / sponsor ID
- 001-Boiskin
- Conditions
- Arteriovenous Fistula
- Keywords
- hemodialysis, fistula, clotting, tranexamic acid, bacitracin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- California Institute of Renal ResearchUniversity, hospital or other
- Collaborators
- Imprimis Pharmaceuticals, Inc.
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clotting time Using Tranexamic Acid 5% | Experimental | Drug: Topical Tranexamic Acid 5% with bacitracinMeasure Native AV Fistula clotting time after dialysis using 5% Tranexamic Acid compared to normal Clotting time of Native AV Fistula after dialysis |
| Clotting Time Using Tranexamic Acid 25% | Experimental | Other: Topical Tranexamic Acid 25% with bacitracinMeasure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dialysis patients with fistulas (native arterio-venous)
Key exclusion criteria (3 listed)
- Previous sensitivity to or adverse reaction to Tranexamic acid or Bacitracin.
- Active infection.
- Stenosis of fistula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Tranexamic Acid 5% with bacitracinAlso: CyklokapronSelected 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. | Drug | Clotting time Using Tranexamic Acid 5% |
| Topical Tranexamic Acid 25% with bacitracinAlso: CyklokapronSelected 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 | Clotting Time Using Tranexamic Acid 25% |
Primary outcome
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
1 secondary outcome
Local Infection
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Fistula
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Boiskin, MD principal investigator
California Institute of Renal Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Tranexamic Acid 5% with bacitracin and Topical Tranexamic Acid 25% with bacitracin in people with Arteriovenous Fistula, run by California Institute of Renal Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clotting TIme (time frame: 13 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.