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| Name | Class |
|---|---|
| Transonic Systems Inc. | INDUSTRY |
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The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).
Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance Group | Active Comparator | Monthly blood flow surveillance by ultrasound dilution technique and standard of care. |
|
| Control Group | No Intervention | Control group will receive standard monitoring (standard care). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transonic | Device | Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemodialysis Access Thrombosis Rate | Evaluate the reduction of hemodialysis access thrombosis rate | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tunneled Hemodialysis Catheter Rate | Evaluate the reduction of tunneled hemodialysis catheter rate | Up to 24 months |
| Number of Participants With a Tunneled Hemodialysis Catheter | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loay Salman, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North America Research Institute | Azusa | California | 91702 | United States | ||
| University of Miami Miller School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surveillance Group | Monthly blood flow surveillance by ultrasound dilution technique and standard of care. Transonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).
|
| FG001 | Control Group | Control group will receive standard monitoring (standard care). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surveillance Group | Monthly blood flow surveillance by ultrasound dilution technique and standard of care. Transonic: Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).
|
| 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 | Hemodialysis Access Thrombosis Rate | Evaluate the reduction of hemodialysis access thrombosis rate | Posted | Number | 95% Confidence Interval | thrombotic events per patient | Up to 24 months |
|
2 years
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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 | Surveillance Group | Monthly standard of care and blood flow surveillance for the duration of the study |
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Study did not achieve targeted numbers for enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Loay Salman, MD | Albany Medical College | 518-262-5176 | SalmanL@amc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2016 | Feb 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Number of Hemodialysis Access Thrombectomy Procedures | Evaluate the reduction of hemodialysis access thrombectomy procedures | Up to 24 months |
| Number of Hemodialysis Access Angiogram and Angioplasty Procedures | Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures | Up to 24 months |
| Miami |
| Florida |
| 33136 |
| United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| BG001 | Control Group | Control group will receive standard monitoring (standard care). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Control group will receive standard monitoring (standard care). |
|
|
| Secondary | Tunneled Hemodialysis Catheter Rate | Evaluate the reduction of tunneled hemodialysis catheter rate | Posted | Number | 95% Confidence Interval | Events per patient | Up to 24 months |
|
|
|
| Secondary | Number of Participants With a Tunneled Hemodialysis Catheter | Posted | Number | participants | Up to 24 months |
|
|
|
| Secondary | Number of Hemodialysis Access Thrombectomy Procedures | Evaluate the reduction of hemodialysis access thrombectomy procedures | Posted | Number | Procedures | Up to 24 months |
|
|
|
| Secondary | Number of Hemodialysis Access Angiogram and Angioplasty Procedures | Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures | Posted | Number | Procedures | Up to 24 months |
|
|
|
| 0 |
| 229 |
| 0 |
| 229 |
| 0 |
| 229 |
| EG001 | Control Group | Monthly standard of care for the duration of the study | 0 | 207 | 0 | 207 | 0 | 207 |
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