Hemodialysis AccessHASENCT02376361

Hemodialysis Access Surveillance Evaluation Study

A study testing Transonic in people with Hemodialysis Access and Thrombosis, run by Albany Medical College at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hemodialysis Access, Thrombosis
What is being tested?: Transonic
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 436 participants
Where: 3 sitesUnited States
Study dates: Mar 2015to Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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
Being tested: Transonic
Keywords: Surveillance
Medical subject headings: Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TransonicDevice
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.

Study groups in NCT02376361
Study group	Role	What they receive
Surveillance Group	Active comparator	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. Receives: Device: Transonic
Control Group	No intervention	Control group will receive standard monitoring (standard care).

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemodialysis Access Thrombosis Rate
Evaluate the reduction of hemodialysis access thrombosis rate
Measured: Up to 24 months

Secondary outcomes (4)

Tunneled Hemodialysis Catheter Rate
Evaluate the reduction of tunneled hemodialysis catheter rate
Measured: Up to 24 months
Number of Participants With a Tunneled Hemodialysis Catheter
Measured: Up to 24 months
Number of Hemodialysis Access Thrombectomy Procedures
Evaluate the reduction of hemodialysis access thrombectomy procedures
Measured: Up to 24 months
Number of Hemodialysis Access Angiogram and Angioplasty Procedures
Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures
Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Jul 2019

First posted3 Mar 2015 (estimated)
Study startMar 2015
Primary completionJul 2019
Study completionJul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hemodialysis AccessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 436 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02376361
Sponsor's protocol ID: 20140235
Acronym: HASE
Status last verified: Feb 2021
First submitted: 24 Feb 2015
Last updated: 23 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
End Stage Renal Disease (ESRD), Kidney Failure
Recruiting
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Venous Stenosis, Venous Occlusion
Recruiting
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
End Stage Renal Disease
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
Not yet recruiting
PATH-03 Paraguay Feasibility Study
Kidney Disease, End-Stage

All Hemodialysis Access trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hemodialysis Access Surveillance Evaluation Study
ClinicalTrials.gov ID: NCT02376361
Acronym / sponsor ID: HASE / 20140235
Conditions: Hemodialysis Access, Thrombosis
Keywords: Surveillance
Study type: Interventional
Recruitment status: Completed
Enrolment: 436 participants (actual)
Lead sponsor: Albany Medical CollegeUniversity, hospital or other
Collaborators: Transonic Systems Inc.
Study start: Mar 2015 (actual)
Primary completion: Jul 2019 (actual)
Study completion: Jul 2019 (actual)
First posted: 3 Mar 2015 (estimated)
Results: Posted 23 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Surveillance Group	Active comparator	Device: TransonicMonthly blood flow surveillance by ultrasound dilution technique and standard of care.
Control Group	No intervention	–Control group will receive standard monitoring (standard care).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TransonicAccess 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.	Device	Surveillance Group

Primary outcome

Hemodialysis Access Thrombosis Rate
Time frame: Up to 24 months
Evaluate the reduction of hemodialysis access thrombosis rate

4 secondary outcomes

Tunneled Hemodialysis Catheter Rate
Time frame: Up to 24 months
Number of Participants With a Tunneled Hemodialysis Catheter
Time frame: Up to 24 months
Number of Hemodialysis Access Thrombectomy Procedures
Time frame: Up to 24 months
Number of Hemodialysis Access Angiogram and Angioplasty Procedures
Time frame: Up to 24 months

Results and safety

Results posted to the registry on 23 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surveillance Group	229	58
Control Group	207	90

Primary outcome: Hemodialysis Access Thrombosis Rate

Time frame: Up to 24 months. Number (95% Confidence Interval). Unit: thrombotic events per patient

Measure	Surveillance Group n = 229	Control Group n = 207
Value	0.122 (0.081 to 0.177)	0.227 (0.167 to 0.302)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surveillance Group	0 of 229 (0%)	0 of 229 (0%)	0 of 229
Control Group	0 of 207 (0%)	0 of 207 (0%)	0 of 207

Limitations and caveats (from the sponsor): Study did not achieve targeted numbers for enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemodialysis Access

Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
End Stage Renal Disease (ESRD), Kidney Failure
Recruiting
The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion
Venous Stenosis, Venous Occlusion
Recruiting
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
End Stage Renal Disease
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
Not yet recruiting
PATH-03 Paraguay Feasibility Study
Kidney Disease, End-Stage

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Loay Salman, MD principal investigator

University of Miami

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transonic in people with Hemodialysis Access and Thrombosis, run by Albany Medical College at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodialysis Access Thrombosis Rate (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02376361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.