Trial Outcomes & Findings for Study of BD Pre-filled Flush Syringes in China (NCT NCT05763147)

Last Updated: 2024-07-30

Results Overview

Evaluation method: Overall performance is assessed by a Nurse, who need to answer the following questions: 1. Can air in the BD Pre-filled Flush Syringes be expelled successfully? 2. Can BD Pre-filled Flush Syringes be connected to the catheter smoothly? 3. Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? 4. Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? 5. Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for flushing and/or locking the catheter is only considered as "success" if: Question 1 to 4 answered with "YES", and question 5 answered with "NO".

Recruitment status

COMPLETED

Study phase

Target enrollment

378 participants

Primary outcome timeframe

one hour after treatment

Results posted on

2024-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	PosiFlush™ Pre-filled Flush Syringes (BD, USA) PosiFlush™ Pre-filled Flush Syringes (BD, USA) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.
Overall Study STARTED	189	189
Overall Study COMPLETED	188	187
Overall Study NOT COMPLETED	1	2

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	PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) n=189 Participants PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	PosiFlush™ Pre-filled Flush Syringes (BD, USA) n=189 Participants PosiFlush™ Pre-filled Flush Syringes (BD, USA) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	Total n=378 Participants Total of all reporting groups
Age, Continuous	55.58 years STANDARD_DEVIATION 17.11 • n=189 Participants	56.15 years STANDARD_DEVIATION 16.87 • n=189 Participants	55.86 years STANDARD_DEVIATION 16.97 • n=378 Participants
Sex: Female, Male Female	82 Participants n=189 Participants	74 Participants n=189 Participants	156 Participants n=378 Participants
Sex: Female, Male Male	107 Participants n=189 Participants	115 Participants n=189 Participants	222 Participants n=378 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	189 participants n=189 Participants	189 participants n=189 Participants	378 participants n=378 Participants
Temperature	36.40 ℃ STANDARD_DEVIATION 0.27 • n=189 Participants	36.42 ℃ STANDARD_DEVIATION 0.30 • n=189 Participants	36.41 ℃ STANDARD_DEVIATION 0.28 • n=378 Participants
Pulse	76.9 beats per minute STANDARD_DEVIATION 10.5 • n=189 Participants	77.6 beats per minute STANDARD_DEVIATION 10.8 • n=189 Participants	77.3 beats per minute STANDARD_DEVIATION 10.6 • n=378 Participants
respiratory rate	18.1 breathes per minute STANDARD_DEVIATION 0.7 • n=189 Participants	18.1 breathes per minute STANDARD_DEVIATION 0.5 • n=189 Participants	18.1 breathes per minute STANDARD_DEVIATION 0.6 • n=378 Participants
Systolic blood pressure, SBP	122.2 millimeters of mercury (mmHG) STANDARD_DEVIATION 13.3 • n=189 Participants	121.3 millimeters of mercury (mmHG) STANDARD_DEVIATION 13.6 • n=189 Participants	121.8 millimeters of mercury (mmHG) STANDARD_DEVIATION 13.5 • n=378 Participants
Diastolic blood pressure, DBP	75.0 millimeters of mercury (mmHG) STANDARD_DEVIATION 8.5 • n=189 Participants	74.9 millimeters of mercury (mmHG) STANDARD_DEVIATION 8.9 • n=189 Participants	74.9 millimeters of mercury (mmHG) STANDARD_DEVIATION 8.7 • n=378 Participants

PRIMARY outcome

Timeframe: one hour after treatment

Population: Number of nurses who is 'success' per the evaluation method For study group, 1 patient withdrew the study and primary endpoint result was not obtained, the other patient met exclusion criteria 4. For control group, 1 patient withdrew the study and primary endpoint result was not obtained, 2 patient met exclusion criteria 4, and the other 1 patient didn't meet inclusion criteria 4. The 6 patients were not included in PPS.

Outcome measures

Outcome measures
Measure	PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) n=187 Participants PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	PosiFlush™ Pre-filled Flush Syringes (BD, USA) n=185 Participants PosiFlush™ Pre-filled Flush Syringes (BD, USA) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.
the Overall Performance for Flushing and / or Locking the Catheters.	187 participants	185 participants

SECONDARY outcome

Timeframe: one hour after treatment

Population: number of nurses who gives '\> 3 easy' For study group, 1 patient withdrew the study and primary endpoint result was not obtained, the other patient met exclusion criteria 4. For control group, 1 patient withdrew the study and primary endpoint result was not obtained, 2 patient met exclusion criteria 4, and the other 1 patient didn't meet inclusion criteria 4. The 6 patients were not included in PPS.

Nurse questionnaire: 1\) Is the plunger easy to push forward when flushing or locking? Score on a 5-point scale: '3' means easy

Outcome measures

Outcome measures
Measure	PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) n=187 Participants PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	PosiFlush™ Pre-filled Flush Syringes (BD, USA) n=185 Participants PosiFlush™ Pre-filled Flush Syringes (BD, USA) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.
Device Ease of Use	187 participants	185 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hour after treatment

Population: For control group, 2 patients didn't use the study devices and were not included in safety set.

Number of adverse events, Incidence of serious adverse events

Outcome measures

Outcome measures
Measure	PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) n=189 Participants PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	PosiFlush™ Pre-filled Flush Syringes (BD, USA) n=187 Participants PosiFlush™ Pre-filled Flush Syringes (BD, USA) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.
Number of Adverse Events and Serious Adverse Events	1 Participants	0 Participants

Adverse Events

PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PosiFlush™ Pre-filled Flush Syringes (BD, USA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) n=189 participants at risk PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.	PosiFlush™ Pre-filled Flush Syringes (BD, USA) n=187 participants at risk PosiFlush™ Pre-filled Flush Syringes (BD, USA) Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment.
Skin and subcutaneous tissue disorders bleeding spot	0.53% 1/189 • Number of events 1 • The time frame consists of 3 time periods: From screening period (Day-2,-1,0), flush syringe treatment period (Day1) to follow-up period (Day 1, 1 hour after the flush syringe treatment). The sponsor shall report to the other clinical trial institutions of medical device, EC, and principal investigators participating in clinical trials, report to the drug regulatory departments of the province, autonomous region and municipality directly under the central government where the sponsor is located.	0.00% 0/187 • The time frame consists of 3 time periods: From screening period (Day-2,-1,0), flush syringe treatment period (Day1) to follow-up period (Day 1, 1 hour after the flush syringe treatment). The sponsor shall report to the other clinical trial institutions of medical device, EC, and principal investigators participating in clinical trials, report to the drug regulatory departments of the province, autonomous region and municipality directly under the central government where the sponsor is located.

Additional Information

MA manager of Clinical Trial

BD China

Phone: 0086 21 2325 4853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place