Hemodialysis Access Surveillance Evaluation Study

Study Overview
=================
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.

Official Title
-----------------
Hemodialysis Access Surveillance Evaluation Study

Conditions
-----------------
Hemodialysis Access, Thrombosis

Intervention / Treatment
-----------------
* Device: Transonic


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surveillance Group<br>Monthly blood flow surveillance by ultrasound dilution technique and standard of care. | Device: Transonic<br>* Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system). Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines Recirculation, access flow will be performed according to HD03 Manual. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.<br>|
| No Intervention: Control Group<br>Control group will receive standard monitoring (standard care). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodialysis Access Thrombosis Rate | Evaluate the reduction of hemodialysis access thrombosis rate | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surveillance