NCT05763147

Study of BD Pre-filled Flush Syringes in China

Completed NA Results posted Last updated 30 July 2024

What this trial tests

NA trial testing Intravenous Access Device Flushing in Effectiveness and Safety of Pre-filled Flush Syringe in 378 participants. Completed in 26 December 2023.

Timeline

3 November 2022

Primary endpoint
26 December 2023

26 December 2023

Quick facts

Lead sponsor	Becton, Dickinson and Company
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	378
Start date	3 November 2022
Primary completion	26 December 2023
Estimated completion	26 December 2023
Sites	3 locations across China

Drugs / interventions tested

• Intravenous Access Device Flushing

Conditions studied

• Effectiveness and Safety of Pre-filled Flush Syringe — all drugs for Effectiveness and Safety of Pre-filled Flush Syringe →

Sponsor

Becton, Dickinson and Company — full company profile →

Who can join

18 and older, any sex, with Effectiveness and Safety of Pre-filled Flush Syringe. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

the Overall Performance for Flushing and / or Locking the Catheters. Primary · one hour after treatment

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:

Group	Value	95% CI
PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)	187
PosiFlush™ Pre-filled Flush Syringes (BD, USA)	185

Device Ease of Use Secondary · one hour after treatment

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

Group	Value	95% CI
PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)	187
PosiFlush™ Pre-filled Flush Syringes (BD, USA)	185

Number of Adverse Events and Serious Adverse Events Secondary · 1 hour after treatment

Number of adverse events, Incidence of serious adverse events

Group	Value	95% CI
PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)	1
PosiFlush™ Pre-filled Flush Syringes (BD, USA)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 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).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

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

Serious: 0/189 (0%)

Deaths: 0/189

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

Serious: 0/187 (0%)

Deaths: 0/187

Other adverse events (1 terms — click to expand)

Reaction	System	PosiFlush™ Pre-filled Flus…	PosiFlush™ Pre-filled Flus…
bleeding spot	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT05763147 adverse events section.

Sponsor's own description

This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.