Hemodialysis Access, Thrombosis
Conditions
Keywords
Surveillance
Brief summary
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.
Interventions
DEVICETransonic
Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system). 1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines 2. Recirculation, access flow will be performed according to HD03 Manual. 3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.
Sponsors
Transonic Systems Inc.
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.
Exclusion criteria
* Patients requiring surgical intervention on the arteriovenous access. * History of access thrombosis (one or more access thrombosis of the current arteriovenous access). * Patients with signs of access infection. * Patients with a malignancy. * Patients with life expectancy of less than six months. * Unable to understand the study. * Unable to sign the consent form. * Patients with psychiatric disorder. * Age less than 18 or greater than 80 years. * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodialysis Access Thrombosis Rate | Up to 24 months | Evaluate the reduction of hemodialysis access thrombosis rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tunneled Hemodialysis Catheter Rate | Up to 24 months | Evaluate the reduction of tunneled hemodialysis catheter rate |
| Number of Participants With a Tunneled Hemodialysis Catheter | Up to 24 months | — |
| Number of Hemodialysis Access Thrombectomy Procedures | Up to 24 months | Evaluate the reduction of hemodialysis access thrombectomy procedures |
| Number of Hemodialysis Access Angiogram and Angioplasty Procedures | Up to 24 months | Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines
2. Recirculation, access flow will be performed according to HD03 Manual.
3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist. | 229 |
| Control Group Control group will receive standard monitoring (standard care). | 207 |
| Total | 436 |
Baseline characteristics
| Characteristic | Surveillance Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 97 Participants | 99 Participants | 196 Participants |
| Age, Categorical Between 18 and 65 years | 132 Participants | 108 Participants | 240 Participants |
| Age, Continuous | 60.996 years STANDARD_DEVIATION 11.855 | 61.826 years STANDARD_DEVIATION 11.942 | 61.4 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Asian/Pacific Islander | 8 participants | 5 participants | 13 participants |
| Race/Ethnicity, Customized black | 43 participants | 43 participants | 86 participants |
| Race/Ethnicity, Customized Hispanic | 136 participants | 93 participants | 229 participants |
| Race/Ethnicity, Customized Not reported | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized White | 40 participants | 61 participants | 101 participants |
| Region of Enrollment United States | 229 participants | 207 participants | 436 participants |
| Sex: Female, Male Female | 80 Participants | 76 Participants | 156 Participants |
| Sex: Female, Male Male | 149 Participants | 131 Participants | 280 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 229 | 0 / 207 |
| other Total, other adverse events | 0 / 229 | 0 / 207 |
| serious Total, serious adverse events | 0 / 229 | 0 / 207 |
Outcome results
Primary
Hemodialysis Access Thrombosis Rate
Evaluate the reduction of hemodialysis access thrombosis rate
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surveillance Group | Hemodialysis Access Thrombosis Rate | 0.122 thrombotic events per patient |
| Control Group | Hemodialysis Access Thrombosis Rate | 0.227 thrombotic events per patient |
Secondary
Number of Hemodialysis Access Angiogram and Angioplasty Procedures
Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surveillance Group | Number of Hemodialysis Access Angiogram and Angioplasty Procedures | 227 Procedures |
| Control Group | Number of Hemodialysis Access Angiogram and Angioplasty Procedures | 203 Procedures |
Secondary
Number of Hemodialysis Access Thrombectomy Procedures
Evaluate the reduction of hemodialysis access thrombectomy procedures
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surveillance Group | Number of Hemodialysis Access Thrombectomy Procedures | 28 Procedures |
| Control Group | Number of Hemodialysis Access Thrombectomy Procedures | 47 Procedures |
Secondary
Number of Participants With a Tunneled Hemodialysis Catheter
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surveillance Group | Number of Participants With a Tunneled Hemodialysis Catheter | 9 participants |
| Control Group | Number of Participants With a Tunneled Hemodialysis Catheter | 11 participants |
Secondary
Tunneled Hemodialysis Catheter Rate
Evaluate the reduction of tunneled hemodialysis catheter rate
Time frame: Up to 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surveillance Group | Tunneled Hemodialysis Catheter Rate | 0.039 Events per patient |
| Control Group | Tunneled Hemodialysis Catheter Rate | 0.053 Events per patient |