Trial Outcomes & Findings for Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer (NCT NCT00659724)

Results Overview

For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows: Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air. Very Difficult:Air could not be removed.

Recruitment status

COMPLETED

Target enrollment

33 participants

Primary outcome timeframe

Priming at each treatment

Results posted on

2025-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Hemodialysis Patients Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
Weeks 1-2: Assessment of 180NR or 200NR STARTED	33
Weeks 1-2: Assessment of 180NR or 200NR COMPLETED	33
Weeks 1-2: Assessment of 180NR or 200NR NOT COMPLETED	0
Weeks 3-4: Assessment of HD-C4 Big STARTED	33
Weeks 3-4: Assessment of HD-C4 Big COMPLETED	33
Weeks 3-4: Assessment of HD-C4 Big NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hemodialysis Patients n=33 Participants Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
Age, Continuous	66.0 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Height	65.6 inches STANDARD_DEVIATION 4.3 • n=5 Participants

PRIMARY outcome

Timeframe: Priming at each treatment

For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows: Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air. Very Difficult:Air could not be removed.

Outcome measures

Outcome measures
Measure	Revaclear MAX n=219 Dialyzers	Optiflux F180NR n=95 Dialyzers	Optiflux F200NR n=97 Dialyzers
Ease of Use: Priming Blood Side Acceptable	80 Number of Dialyzers	82 Number of Dialyzers	84 Number of Dialyzers
Ease of Use: Priming Blood Side Very Easy	139 Number of Dialyzers	13 Number of Dialyzers	13 Number of Dialyzers

PRIMARY outcome

Timeframe: Priming at each treatment

For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows: Dialysate Side at 500 ml Priming Volume (check one): Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air.

Outcome measures

Outcome measures
Measure	Revaclear MAX n=220 Dialyzers	Optiflux F180NR n=95 Dialyzers	Optiflux F200NR n=97 Dialyzers
Ease of Use: Priming Dialysate Side Perfect	131 Number of Dialyzers	4 Number of Dialyzers	2 Number of Dialyzers
Ease of Use: Priming Dialysate Side Acceptable	89 Number of Dialyzers	91 Number of Dialyzers	95 Number of Dialyzers

PRIMARY outcome

Timeframe: Each treatment: assessment of the condition of the dialyzer fibers after rinse-back

For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows: Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)

Outcome measures

Outcome measures
Measure	Revaclear MAX n=218 Dialyzers	Optiflux F180NR n=95 Dialyzers	Optiflux F200NR n=97 Dialyzers
Dialyzer Assessment: Fiber Condition Very Good	126 Number of Dialyzers	23 Number of Dialyzers	15 Number of Dialyzers
Dialyzer Assessment: Fiber Condition Good	75 Number of Dialyzers	44 Number of Dialyzers	45 Number of Dialyzers
Dialyzer Assessment: Fiber Condition Poor	12 Number of Dialyzers	17 Number of Dialyzers	30 Number of Dialyzers
Dialyzer Assessment: Fiber Condition Very Poor	5 Number of Dialyzers	11 Number of Dialyzers	7 Number of Dialyzers

PRIMARY outcome

Timeframe: Each treatment: assessment of the condition of the arterial header after rinse-back

For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.

Outcome measures

Outcome measures
Measure	Revaclear MAX n=218 Dialyzers	Optiflux F180NR n=95 Dialyzers	Optiflux F200NR n=96 Dialyzers
Dialyzer Assessment: Arterial Header Condition Very Good	155 Number of Dialyzers	0 Number of Dialyzers	0 Number of Dialyzers
Dialyzer Assessment: Arterial Header Condition Good	49 Number of Dialyzers	66 Number of Dialyzers	64 Number of Dialyzers
Dialyzer Assessment: Arterial Header Condition Poor	13 Number of Dialyzers	26 Number of Dialyzers	30 Number of Dialyzers
Dialyzer Assessment: Arterial Header Condition Very Poor	1 Number of Dialyzers	3 Number of Dialyzers	2 Number of Dialyzers

PRIMARY outcome

Timeframe: Each treatment: the assessment of the condition of the venous header after rinse-back

For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.

Outcome measures

Outcome measures
Measure	Revaclear MAX n=217 Dialyzers	Optiflux F180NR n=94 Dialyzers	Optiflux F200NR n=97 Dialyzers
Dialyzer Assessment: Venous Header Condition Very Good	65 Number of Dialyzers	0 Number of Dialyzers	0 Number of Dialyzers
Dialyzer Assessment: Venous Header Condition Good	140 Number of Dialyzers	31 Number of Dialyzers	35 Number of Dialyzers
Dialyzer Assessment: Venous Header Condition Poor	7 Number of Dialyzers	52 Number of Dialyzers	57 Number of Dialyzers
Dialyzer Assessment: Venous Header Condition Very Poor	5 Number of Dialyzers	11 Number of Dialyzers	5 Number of Dialyzers

Adverse Events

Hemodialysis Patients

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

Global CORP Clinical Trials Disclosure

Vantive

Phone: +1 2249484283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place