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Completed

NCT Number: NCT02376361

Hemodialysis Access Surveillance Evaluation Study

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.

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Key information

Conditions

Hemodialysis Access Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North America Research Institute, Azusa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transonic

Device

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 outcomes

  1. Hemodialysis Access Thrombosis Rate

    Time frame: Up to 24 months

    Evaluate the reduction of hemodialysis access thrombosis rate

Secondary outcomes

  1. Tunneled Hemodialysis Catheter Rate

    Time frame: Up to 24 months

    Evaluate the reduction of tunneled hemodialysis catheter rate

  2. Number of Participants With a Tunneled Hemodialysis Catheter

    Time frame: Up to 24 months

  3. Number of Hemodialysis Access Thrombectomy Procedures

    Time frame: Up to 24 months

    Evaluate the reduction of hemodialysis access thrombectomy procedures

  4. Number of Hemodialysis Access Angiogram and Angioplasty Procedures

    Time frame: Up to 24 months

    Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Collaborators

  • Transonic Systems Inc.

Registry information

Acronym: HASE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2015
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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