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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | Experimental | PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) |
|
| PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Active Comparator | PosiFlush™ Pre-filled Flush Syringes (BD, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Access Device Flushing | Device | locking and flushing the end of catheter line at the intervals of different drug treatment. |
|
| 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:
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 |
| 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 |
| 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 |
Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Chao Chao | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | 200040 | China | |||
| Beijing Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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". | 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. | Posted | Number | participants | one hour after treatment |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding spot | Skin and subcutaneous tissue disorders | MedDRA 25.1 Chinese | Systematic Assessment | scattered subcutaneous bleeding spots |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MA manager of Clinical Trial | BD China | 0086 21 2325 4853 | justina.zhu@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2022 | Mar 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2023 | Mar 25, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2022 | Mar 25, 2024 | ICF_002.pdf |
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| Beijing |
| 200040 |
| China |
| Beijing Jishuitan Hospital | Beijing | 200040 | China |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Temperature | Mean | Standard Deviation | ℃ |
|
| Pulse | Mean | Standard Deviation | beats per minute |
|
| respiratory rate | Mean | Standard Deviation | breathes per minute |
|
| Systolic blood pressure, SBP | Mean | Standard Deviation | millimeters of mercury (mmHG) |
|
| Diastolic blood pressure, DBP | Mean | Standard Deviation | millimeters of mercury (mmHG) |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
| Secondary | 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 | 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. | Posted | Number | participants | one hour after treatment |
|
|
|
| Other Pre-specified | Number of Adverse Events and Serious Adverse Events | Number of adverse events, Incidence of serious adverse events | For control group, 2 patients didn't use the study devices and were not included in safety set. | Posted | Count of Participants | Participants | 1 hour after treatment |
|
|
|
| 0 |
| 189 |
| 0 |
| 189 |
| 1 |
| 189 |
| EG001 | 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. | 0 | 187 | 0 | 187 | 0 | 187 |
|
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