Hemodialysis Access Surveillance Evaluation Study

Thrombosis Clinical Trial

— HASE  

Official title:

Hemodialysis Access Surveillance Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376361
• Other study ID #: 20140235
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2019

Study information

• Verified date: February 2021
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Access
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	North America Research Institute	Azusa	California
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Albany Medical College	Transonic Systems Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodialysis Access Thrombosis Rate	Evaluate the reduction of hemodialysis access thrombosis rate	Up to 24 months
Secondary	Tunneled Hemodialysis Catheter Rate	Evaluate the reduction of tunneled hemodialysis catheter rate	Up to 24 months
Secondary	Number of Participants With a Tunneled Hemodialysis Catheter		Up to 24 months
Secondary	Number of Hemodialysis Access Thrombectomy Procedures	Evaluate the reduction of hemodialysis access thrombectomy procedures	Up to 24 months
Secondary	Number of Hemodialysis Access Angiogram and Angioplasty Procedures	Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures	Up to 24 months