N/A
N=436
Hemodialysis Access Surveillance Evaluation Study
Hemodialysis Access · Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT02376361 ↗Enrolled (actual)
436
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Hemodialysis Access Thrombosis Rate — 0.122; 0.227 thrombotic events per patient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transonic (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albany Medical College
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemodialysis Access Thrombosis Rate |
0.122; 0.227 | — |
| SECONDARY Tunneled Hemodialysis Catheter Rate |
0.039; 0.053 | — |
| SECONDARY Number of Participants With a Tunneled Hemodialysis Catheter |
9; 11 | — |
| SECONDARY Number of Hemodialysis Access Thrombectomy Procedures |
28; 47 | — |
| SECONDARY Number of Hemodialysis Access Angiogram and Angioplasty Procedures |
227; 203 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02376361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.