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| Name | Class |
|---|---|
| Imprimis Pharmaceuticals, Inc. | INDUSTRY |
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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
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Tranexamic Acid 5% with bacitracin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 13 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Local Infection | After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Boiskin, MD | California Institute of Renal Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresenius Medical Care - Kearny Mesa | San Diego | California | 92111 | United States | ||
| California Insitute of Renal Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Tranexamic Acid 5% | Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time. |
| FG001 | Topical Tranexamic Acid 25% | Topical Tranexamic Acid 25% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
dialysis subjects using arteriovenous fistula for dialysis access
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Tranexamic Acid and Bacitracin 25% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Full Range | minutes | 13 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Tranexamic Acid 5% and Bacitracin | Topical Tranexamic Acid 5% with bacitracin applied to the arterio-venous fistula site after completing dialysis, to measure clotting time. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark M. Boiskin, M.D. | California Insitute of Renal Research, Inc. | 858-637-4600 | mboiskin@bnmg.org |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| D005402 | Fistula |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D001414 | Bacitracin |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Topical Tranexamic Acid 25% with bacitracin | Other | 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. |
|
|
| San Diego |
| California |
| 92123 |
| United States |
| Fresenious Medical Care - Rancho | San Diego | California | 92127 | United States |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Measure Native AV Fistula clotting time after dialysis using 25% Tranxemic Acid compared to normal clotting time of native AV Fistula after dialysis 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. |
|
|
| Secondary | Local Infection | After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study | no local infection in any particioant | Posted | Mean | Full Range | participants | 2 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Topical Tranexamic Acid 25% and Bacitracin | Topical Tranexamic Acid 25% with bacitracin was applied to the arterio-venous fistula site after completing dialysis, to measure clotting time at a subsequent dialysis session. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |