Hemodialysis Access Surveillance Evaluation Study (HASE)

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis; Hemodialysis Access
• Intervention / Treatment: Device: Transonic

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • North America Research Institute
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surveillance Group; Monthly blood flow surveillance by ultrasound dilution technique and standard of care.	Device: Transonic; 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.
No Intervention: Control Group; 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

Collaborators and Investigators

• Sponsor: Albany Medical College
• Collaborators: Transonic Systems Inc.
• Investigators: Principal Investigator: Loay Salman, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Surveillance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 20140235