Trial Outcomes & Findings for Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis (NCT NCT02914132)

Results Overview

Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

14 days

Results posted on

2019-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Seraph 100 Filter Renal replacement patient with bacteremia. Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seraph 100 Filter n=15 Participants Renal replacement patient with bacteremia. Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia.
Age, Continuous	73 years STANDARD_DEVIATION 9.8 • n=15 Participants
Sex: Female, Male Female	3 Participants n=15 Participants
Sex: Female, Male Male	12 Participants n=15 Participants
Region of Enrollment Germany	15 Participants n=15 Participants

PRIMARY outcome

Timeframe: 14 days

Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured

Outcome measures

Outcome measures
Measure	Seraph 100 Filter n=15 Participants Renal replacement patient with bacteremia. Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia.
Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.	0 Percent participants w adverse event

SECONDARY outcome

Timeframe: 4 hours

Pathogen reduction of \> 40 % as CFU/mL or an increase in time to positivity (TTP) of \> 22 minutes in blood passed through the Seraph 100 Filter

Outcome measures

Outcome measures
Measure	Seraph 100 Filter n=4 Participants Renal replacement patient with bacteremia. Seraph 100 Filter: Treatment of renal replacement therapy patients with bacteremia.
Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter.	4 Participants

Adverse Events

Seraph 100 Filter

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

Sr. Director of Regulatory and Clinical Affairs

ExThera Medical Corporation

Phone: 9258392079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place