HASE: Hemodialysis Access Surveillance Evaluation Study

• Sponsor: Albany Medical College (Other)
• Overall Status: Completed
• CT.gov ID: NCT02376361
• Collaborator: Transonic Systems Inc. (Industry)
• Enrollment: 436
• Locations: 3
• Arms: 2
• Actual Duration (Months): 52
• Patients Per Site: 145.3
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Access; Thrombosis	Device: Transonic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 436 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Hemodialysis Access Surveillance Evaluation Study
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surveillance Group Monthly blood flow surveillance by ultrasound dilution technique and standard of care.	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.
No Intervention: Control Group Control group will receive standard monitoring (standard care).

Outcome Measures

Primary Outcome Measures

1. Hemodialysis Access Thrombosis Rate [Up to 24 months]

   Evaluate the reduction of hemodialysis access thrombosis rate

Secondary Outcome Measures

1. Tunneled Hemodialysis Catheter Rate [Up to 24 months]

   Evaluate the reduction of tunneled hemodialysis catheter rate

2. Number of Participants With a Tunneled Hemodialysis Catheter [Up to 24 months]

3. Number of Hemodialysis Access Thrombectomy Procedures [Up to 24 months]

   Evaluate the reduction of hemodialysis access thrombectomy procedures

4. Number of Hemodialysis Access Angiogram and Angioplasty Procedures [Up to 24 months]

   Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North America Research Institute	Azusa	California	United States	91702
2	University of Miami Miller School of Medicine	Miami	Florida	United States	33136
3	Albany Medical College	Albany	New York	United States	12208

Sponsors and Collaborators

• Albany Medical College
• Transonic Systems Inc.

Investigators

• Principal Investigator: Loay Salman, MD, University of Miami

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 27, 2016

More Information

Publications

None provided.

• Responsible Party: Loay Salman, MD, Professor of Medicine, Albany Medical College
• ClinicalTrials.gov Identifier: NCT02376361
• Other Study ID Numbers: 20140235
• First Posted: Mar 3, 2015
• Last Update Posted: Feb 23, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Loay Salman, MD, Professor of Medicine, Albany Medical College: Surveillance
• Additional relevant MeSH terms: Thrombosis

Study Results

Participant Flow

Arm/Group Title	Surveillance Group	Control Group
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).
Period Title: Overall Study
STARTED	229	207
COMPLETED	58	90
NOT COMPLETED	171	117

Baseline Characteristics

Arm/Group Title	Surveillance Group	Control Group	Total
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).	Total of all reporting groups
Overall Participants	229	207	436
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	132 57.6%	108 52.2%	240 55%
>=65 years	97 42.4%	99 47.8%	196 45%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.996 (11.855)	61.826 (11.942)	61.4 (11.9)
Sex: Female, Male (Count of Participants)
Female	80 34.9%	76 36.7%	156 35.8%
Male	149 65.1%	131 63.3%	280 64.2%
Race/Ethnicity, Customized (participants) [Number]
black	43 18.8%	43 20.8%	86 19.7%
Hispanic	136 59.4%	93 44.9%	229 52.5%
White	40 17.5%	61 29.5%	101 23.2%
Asian/Pacific Islander	8 3.5%	5 2.4%	13 3%
Not reported	2 0.9%	5 2.4%	7 1.6%
Region of Enrollment (participants) [Number]
United States	229 100%	207 100%	436 100%

Outcome Measures

1. Primary Outcome

Title	Hemodialysis Access Thrombosis Rate
Description	Evaluate the reduction of hemodialysis access thrombosis rate
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Group	Control Group
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).
Measure Participants	229	207
Number (95% Confidence Interval) [thrombotic events per patient]	0.122	0.227

2. Secondary Outcome

Title	Tunneled Hemodialysis Catheter Rate
Description	Evaluate the reduction of tunneled hemodialysis catheter rate
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Group	Control Group
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).
Measure Participants	229	207
Number (95% Confidence Interval) [Events per patient]	0.039	0.053

3. Secondary Outcome

Title	Number of Participants With a Tunneled Hemodialysis Catheter
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Group	Control Group
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).
Measure Participants	229	207
Number [participants]	9 3.9%	11 5.3%

4. Secondary Outcome

Title	Number of Hemodialysis Access Thrombectomy Procedures
Description	Evaluate the reduction of hemodialysis access thrombectomy procedures
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Group	Control Group
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).
Measure Participants	229	207
Number [Procedures]	28	47

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Surveillance Group	Control Group
Arm/Group Description	Monthly blood flow surveillance by ultrasound dilution technique and standard of care. 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.	Control group will receive standard monitoring (standard care).
Measure Participants	229	207
Number [Procedures]	227	203

Adverse Events

Time Frame	2 years
Arm/Group Title	Surveillance Group		Control Group
Arm/Group Description	Monthly standard of care and blood flow surveillance for the duration of the study		Monthly standard of care for the duration of the study
All Cause Mortality
	Surveillance Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/229 (0%)		0/207 (0%)
Serious Adverse Events
	Surveillance Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/229 (0%)		0/207 (0%)
Other (Not Including Serious) Adverse Events
	Surveillance Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/229 (0%)		0/207 (0%)

Limitations/Caveats

Study did not achieve targeted numbers for enrollment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.