Trial Outcomes & Findings for Propaten Randomized Investigation on Cost-benefit and Efficacy (NCT NCT01601873)

NCT ID: NCT01601873

Last Updated: 2019-02-27

Results Overview

Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-02-27

Participant Flow

103 were enrolled, but only 97 started (a difference of 6 subjects). These 6 subjects who were enrolled but did not start the study presented to the day-surgery operating room but had not followed instructions to stop Coumadin; therefore, their cases were cancelled.

Participant milestones

Measure	PROPATEN patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Overall Study STARTED	50	47
Overall Study COMPLETED	48	44
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	PROPATEN patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Propaten Randomized Investigation on Cost-benefit and Efficacy

Baseline characteristics by cohort

Measure	PROPATEN n=50 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=47 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft	Total n=97 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 12.6 • n=5 Participants	65 years STANDARD_DEVIATION 11.9 • n=7 Participants	64.6 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	42 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 1 in the propaten arm and 3 in the standard graft arm were lost to follow up.

Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

Outcome measures

Measure	PROPATEN n=49 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Primary Graft Patency Rate	35 Percentage of participants	33 Percentage of participants

PRIMARY outcome

Timeframe: 12 months

Population: 1 in the propaten arm and 3 in the standard graft arm were lost to follow up.

Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.

Outcome measures

Measure	PROPATEN n=49 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Primary-Assisted Graft Patency Rate	57 Percentage of participants	60 Percentage of participants

PRIMARY outcome

Timeframe: 12 months

Population: 1 in the propaten arm and 3 in the standard graft arm were lost to follow up.

Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

Outcome measures

Measure	PROPATEN n=49 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Secondary Graft Patency Rate	62 Percentage of participants	52 Percentage of participants

PRIMARY outcome

Timeframe: 24 months after graft placement

Population: 2 in the propaten group and 3 in the standard graft group were lost to follow up.

Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.

Outcome measures

Measure	PROPATEN n=48 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Primary Graft Patency Rate	24 Percentage of participants	25 Percentage of participants

PRIMARY outcome

Timeframe: 24 months after graft placement

Population: 2 in the propaten group and 3 in the standard graft group were lost to follow up.

Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.

Outcome measures

Measure	PROPATEN n=48 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Primary-Assisted Graft Patency Rate	26 Percentage of participants	22 Percentage of participants

PRIMARY outcome

Timeframe: 24 months after graft placement

Population: 2 in the propaten group and 3 in the standard graft group were lost to follow up.

Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

Outcome measures

Measure	PROPATEN n=48 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Secondary Graft Patency Rate	48 Percentage of participants	38 Percentage of participants

SECONDARY outcome

Timeframe: at least 1 year but up to two years

Population: 2 in the propaten group and 3 in the standard graft group were lost to follow up.

Complication/morbidity associated with both types of interventions

Outcome measures

Measure	PROPATEN n=48 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Number of Participants With Complications or Morbidity Attributable to the Study	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the study period based on an average participant follow-up of 2 years after graft placement

Population: The cost data were not collected.

Will be based on the difference between total cost analysed on the basis of the specific graft price, cost of re-intervention procedures if any, treatment of complications, hospital stay, etc., and compared for each study arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants would be followed for a period of 2 years after graft placement

Population: Qol data was collected, but because results of a planned interim futility analysis did not meet the study criteria for continuation, we do not believe analysis of the QoL data would be meaningful. Analysis of QoL data is an extremely onerous process that would take months to conduct. It is not worth the resources required to perform this analysis.

Comparative assessment of quality of life reported by the patients in two arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at least 1 year but up to two years

Population: 2 in the propaten group and 3 in the standard graft group were lost to follow up.

Outcome measures

Measure	PROPATEN n=48 Participants patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 Participants patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Number of Postoperative Re-interventions	2.7 post-operative re-interventions Standard Deviation 5.0	2.0 post-operative re-interventions Standard Deviation 2.5

Adverse Events

PROPATEN

Serious events: 0 serious events

Other events: 19 other events

Deaths: 7 deaths

Standard Graft

Serious events: 0 serious events

Other events: 20 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PROPATEN n=48 participants at risk patients with heparin-bonded graft implantation PROPATEN: Heparin-bonded graft implantation for hemodialysis vascular access	Standard Graft n=44 participants at risk patients undergoing ePTFE hemodialysis graft implantation Standard Graft: non-heparin bonded conventional hemodialysis vascular access graft
Vascular disorders stenosis	14.6% 7/48 • Number of events 7 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)	18.2% 8/44 • Number of events 8 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)
Surgical and medical procedures Unable to cannulate	14.6% 7/48 • Number of events 7 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)	11.4% 5/44 • Number of events 5 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)
Surgical and medical procedures Graft site bleeding	4.2% 2/48 • Number of events 2 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)	0.00% 0/44 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)
Vascular disorders Vascular steal requiring intervention	6.2% 3/48 • Number of events 3 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)	6.8% 3/44 • Number of events 3 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)
Vascular disorders Pseudoaneurysm	0.00% 0/48 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)	4.5% 2/44 • Number of events 2 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)
Vascular disorders Failure to mature	0.00% 0/48 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)	4.5% 2/44 • Number of events 2 • At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year)

Additional Information

Kristofer Charlton-Ouw, MD

The University of Texas Health Science Center at Houston

Phone: (713) 486-5117

Email: Kristofer.CharltonOuw@uth.tmc.edu

Results disclosure agreements

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