Study of BD Pre-filled Flush Syringes in China

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-12-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Effectiveness and Safety of Pre-filled Flush Syringe

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

Intravenous Access Device Flushing

Intervention Type DEVICE

locking and flushing the end of catheter line at the intervals of different drug treatment.

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

Group Type ACTIVE_COMPARATOR

Intravenous Access Device Flushing

Intervention Type DEVICE

locking and flushing the end of catheter line at the intervals of different drug treatment.

Interventions

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Intravenous Access Device Flushing

locking and flushing the end of catheter line at the intervals of different drug treatment.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No