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Hemodialysis Access Surveillance Evaluation Study (HASE)

Primary Purpose

Hemodialysis Access, Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transonic
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hemodialysis Access focused on measuring Surveillance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North America Research Institute
  • University of Miami Miller School of Medicine
  • Albany Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Surveillance Group

Control Group

Arm Description

Monthly blood flow surveillance by ultrasound dilution technique and standard of care.

Control group will receive standard monitoring (standard care).

Outcomes

Primary Outcome Measures

Hemodialysis Access Thrombosis Rate
Evaluate the reduction of hemodialysis access thrombosis rate

Secondary Outcome Measures

Tunneled Hemodialysis Catheter Rate
Evaluate the reduction of tunneled hemodialysis catheter rate
Number of Participants With a Tunneled Hemodialysis Catheter
Number of Hemodialysis Access Thrombectomy Procedures
Evaluate the reduction of hemodialysis access thrombectomy procedures
Number of Hemodialysis Access Angiogram and Angioplasty Procedures
Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures

Full Information

First Posted
February 24, 2015
Last Updated
February 4, 2021
Sponsor
Albany Medical College
Collaborators
Transonic Systems Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02376361
Brief Title
Hemodialysis Access Surveillance Evaluation Study
Acronym
HASE
Official Title
Hemodialysis Access Surveillance Evaluation Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
Collaborators
Transonic Systems Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Access, Thrombosis
Keywords
Surveillance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surveillance Group
Arm Type
Active Comparator
Arm Description
Monthly blood flow surveillance by ultrasound dilution technique and standard of care.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will receive standard monitoring (standard care).
Intervention Type
Device
Intervention Name(s)
Transonic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemodialysis Access Thrombosis Rate
Description
Evaluate the reduction of hemodialysis access thrombosis rate
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Tunneled Hemodialysis Catheter Rate
Description
Evaluate the reduction of tunneled hemodialysis catheter rate
Time Frame
Up to 24 months
Title
Number of Participants With a Tunneled Hemodialysis Catheter
Time Frame
Up to 24 months
Title
Number of Hemodialysis Access Thrombectomy Procedures
Description
Evaluate the reduction of hemodialysis access thrombectomy procedures
Time Frame
Up to 24 months
Title
Number of Hemodialysis Access Angiogram and Angioplasty Procedures
Description
Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loay Salman, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
North America Research Institute
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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Hemodialysis Access Surveillance Evaluation Study

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