Hemodialysis Access Surveillance Evaluation Study

NCT02376361 | Completed Results

• 1 other identifier: 20140235
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemodialysis Access; Thrombosis

Keywords

Surveillance

Outcome Measures

Primary Outcomes (1)

• Hemodialysis Access Thrombosis Rate

  Evaluate the reduction of hemodialysis access thrombosis rate

  Up to 24 months

Secondary Outcomes (4)

• 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

  Up to 24 months

• Number of Hemodialysis Access Angiogram and Angioplasty Procedures

  Up to 24 months

Study Arms (2)

Surveillance Group

ACTIVE COMPARATOR

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

Device: Transonic

Control Group

NO INTERVENTION

Control group will receive standard monitoring (standard care).

Interventions

Transonic DEVICE

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.

Surveillance Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead
• Transonic Systems Inc.: collaborator

Study Sites (3)

North America Research Institute

Azusa, California, 91702, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study did not achieve targeted numbers for enrollment.

Results Point of Contact

• Title: Loay Salman, MD
• Organization: Albany Medical College

SalmanL@amc.edu

518-262-5176

Study Officials

• Loay Salman, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Locations

US (3)