Study of BD Pre-filled Flush Syringes in China

A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes

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.

Study Overview

• Status: Completed
• Conditions: Effectiveness and Safety of Pre-filled Flush Syringe
• Intervention / Treatment: Device: Intravenous Access Device Flushing

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 200040
    • Beijing Friendship Hospital
  • Beijing, China, 200040
    • Beijing Hospital
  • Beijing, China, 200040
    • Beijing Jishuitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Age >or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form.

Exclusion Criteria:

• 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial.

  3. Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial.

  4. Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)	Device: Intravenous Access Device Flushing; locking and flushing the end of catheter line at the intervals of different drug treatment.
Active Comparator: PosiFlush™ Pre-filled Flush Syringes (BD, USA)	Device: Intravenous Access Device Flushing; locking and flushing the end of catheter line at the intervals of different drug treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Overall Performance for Flushing and / or Locking the Catheters.	Evaluation method: Overall performance is assessed by a Nurse, who need to answer the following questions: Can air in the BD Pre-filled Flush Syringes be expelled successfully?; Can BD Pre-filled Flush Syringes be connected to the catheter smoothly?; Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully?; Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly?; 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".	one hour after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Ease of Use	Nurse questionnaire: 1) Is the plunger easy to push forward when flushing or locking? Score on a 5-point scale: '3' means easy	one hour after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events and Serious Adverse Events	Number of adverse events, Incidence of serious adverse events	1 hour after treatment

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Chao Chao, Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): December 26, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Flushing
• Other Study ID Numbers: MDS-21FLUSHCN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes