Arteriovenous Fistula
Conditions
Keywords
hemodialysis, fistula, clotting, tranexamic acid, bacitracin
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
Interventions
DRUGTopical 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.
OTHERTopical 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.
Sponsors
Imprimis Pharmaceuticals, Inc.
California Institute of Renal Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clotting TIme | 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
| Measure | Time frame | Description |
|---|---|---|
| Local Infection | 2 months | After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Tranexamic Acid and Bacitracin 5% Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that did not receive treatment at a subsequent dialysis session | 8 |
| Tranexamic Acid and Bacitracin 25% Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time in the same participants that received treatment but at a subsequent dialysis session. | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Topical Tranexamic Acid and Bacitracin 5% | Tranexamic Acid and Bacitracin 25% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
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
Time frame: 13 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clotting Time Using Tranexamic Acid 5% | Clotting TIme | 6 minutes |
| Clotting Time Using Tranexamic Acid 25% | Clotting TIme | 8 minutes |
Secondary
Local Infection
After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study
Time frame: 2 months
Population: no local infection in any particioant
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clotting Time Using Tranexamic Acid 5% | Local Infection | 0 participants |
| Clotting Time Using Tranexamic Acid 25% | Local Infection | 0 participants |