Trial Outcomes & Findings for Hemodialysis Access Surveillance Evaluation Study (NCT NCT02376361)

NCT ID: NCT02376361

Last Updated: 2021-02-23

Results Overview

Evaluate the reduction of hemodialysis access thrombosis rate

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 436 participants
• Primary outcome timeframe: Up to 24 months
• Results posted on: 2021-02-23

Participant Flow

Participant milestones

Measure	Surveillance Group 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). 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.	Control Group Control group will receive standard monitoring (standard care).
Overall Study STARTED	229	207
Overall Study COMPLETED	58	90
Overall Study NOT COMPLETED	171	117

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodialysis Access Surveillance Evaluation Study

Baseline characteristics by cohort

Measure	Surveillance Group n=229 Participants 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). 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.	Control Group n=207 Participants Control group will receive standard monitoring (standard care).	Total n=436 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	132 Participants n=5 Participants	108 Participants n=7 Participants	240 Participants n=5 Participants
Age, Categorical >=65 years	97 Participants n=5 Participants	99 Participants n=7 Participants	196 Participants n=5 Participants
Age, Continuous	60.996 years STANDARD_DEVIATION 11.855 • n=5 Participants	61.826 years STANDARD_DEVIATION 11.942 • n=7 Participants	61.4 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	76 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	149 Participants n=5 Participants	131 Participants n=7 Participants	280 Participants n=5 Participants
Race/Ethnicity, Customized black	43 participants n=5 Participants	43 participants n=7 Participants	86 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	136 participants n=5 Participants	93 participants n=7 Participants	229 participants n=5 Participants
Race/Ethnicity, Customized White	40 participants n=5 Participants	61 participants n=7 Participants	101 participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized Not reported	2 participants n=5 Participants	5 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	229 participants n=5 Participants	207 participants n=7 Participants	436 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Evaluate the reduction of hemodialysis access thrombosis rate

Outcome measures

Measure	Surveillance Group n=229 Participants 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). 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.	Control Group n=207 Participants Control group will receive standard monitoring (standard care).
Hemodialysis Access Thrombosis Rate	0.122 thrombotic events per patient Interval 0.081 to 0.177	0.227 thrombotic events per patient Interval 0.167 to 0.302

SECONDARY outcome

Timeframe: Up to 24 months

Evaluate the reduction of tunneled hemodialysis catheter rate

Outcome measures

Measure	Surveillance Group n=229 Participants 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). 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.	Control Group n=207 Participants Control group will receive standard monitoring (standard care).
Tunneled Hemodialysis Catheter Rate	0.039 Events per patient Interval 0.018 to 0.075	0.053 Events per patient Interval 0.027 to 0.095

SECONDARY outcome

Timeframe: Up to 24 months

Outcome measures

Measure	Surveillance Group n=229 Participants 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). 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.	Control Group n=207 Participants Control group will receive standard monitoring (standard care).
Number of Participants With a Tunneled Hemodialysis Catheter	9 participants	11 participants

SECONDARY outcome

Timeframe: Up to 24 months

Evaluate the reduction of hemodialysis access thrombectomy procedures

Outcome measures

Measure	Surveillance Group n=229 Participants 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). 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.	Control Group n=207 Participants Control group will receive standard monitoring (standard care).
Number of Hemodialysis Access Thrombectomy Procedures	28 Procedures	47 Procedures

SECONDARY outcome

Timeframe: Up to 24 months

Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures

Outcome measures

Measure	Surveillance Group n=229 Participants 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). 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.	Control Group n=207 Participants Control group will receive standard monitoring (standard care).
Number of Hemodialysis Access Angiogram and Angioplasty Procedures	227 Procedures	203 Procedures

Adverse Events

Surveillance Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Loay Salman, MD

Albany Medical College

Phone: 518-262-5176

Email: SalmanL@amc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place