Subarachnoid HemorrhageNCT04309708
Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy
A study testing Nimodipine pump infusion in people with Subarachnoid Hemorrhage, run by B. Braun Medical International Trading Company Ltd. at 5 sites in China.
Trial summary
To verify the efficacy and safety of Original Perfusor Line (Art.No.8723017) in infusion therapy in Patients with light sensitive drug infusion. Subjects who choose to use Original Perfusor Line for their planned infusion treatment (nimodipine injection) as per the study protocol will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Nimodipine pump infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2018to 8 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years, all genders;
- Patients who will be treated plan to use injection pump for infusion treatment with nimodipine injection by infusion pump.
- Participated in this study voluntarily and signed informed consent form.
Who cannot join
- Patients have contraindication on Nimodipine.
- Patients allergic to polyethylene (PE) material;
- Patients with aspartate transaminase(AST) and alanine transaminase(ALT) are 2 times higher than normal range, Serum creatinine(Scr) is 1.5 times higher than normal range.
- Patient with malignant tumor, pregnant or Lactation;
- Patients had participated in other clinical trials within 1 month and in parallel with other trials;
- Patients are unsuitable to participate in this study as judged by the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Sanbo Brain Hospital, Captial Medical University
Beijing, Beijing Municipality, 100093
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: A Prospective, Randomized, Cntrolled, Multi-center Clinical Study on Efficacy and Safety of Infusion Therapy by Comparing Original Perfusor Line (Orange,Art No.8723017) With Original Perfusor Line (Black,Art No.8723010) in Pump Infusion.
To verify the efficacy and safety of Original Perfusor Line (Art.No.8723017) in infusion therapy in Patients with light sensitive drug infusion.
Subjects who choose to use Original Perfusor Line for their planned infusion treatment (nimodipine injection) as per the study protocol will be enrolled. The 300 subjects will be 1:1 randomized into the experimental group or the control group, using Original Perfusor Line (Art.No. 8723017) connected with an injection pump for infusion treatment with nimodipine injection or Original Perfusor Line (Art.No.8723010) connected with an injection pump for infusion treatment with nimodipine injection, respectively.Use of both the test product and the control product will be in strict accordance with their package insert.
The primary endpoint is the percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications, visible catheter embolism, air embolism and micro embolism in the infusion system and the secondary endpoint is the quality assessment for the clinical application of the products,such as the percentage of products which are qualified for infusion administration including link and removal, transparence, and tenacity.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Nimodipine pump infusion
- Keywords
- pump infusion, photodegradation, IV infusion therapy
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimodipine pump infusionDevice
Patients with nimodipine pump infusion with pump infusion line and other infusion equipments
| Study group | Role | What they receive |
|---|---|---|
| Original Perfusor Line(Art.No.8723017) | Experimental | Not described Receives: Device: Nimodipine pump infusion |
| Original Perfusor Line(Art.No.8723010) | Active comparator | Not described Receives: Device: Nimodipine pump infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infusion success rate
The percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications
Measured: 2 hours after infusion therapy completion
Secondary outcomes (1)
Product pass rate
percentage of the quantity of products that pass the evaluation in the sum of products that pass the evaluation and products that fail the evaluation.
Measured: 2 hours after infusion therapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 May 2018
- Primary completion6 Sep 2019
- Study completion8 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Controlled, Parallel, Multi-center study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li ping Liu, Prof., Principal investigator, Beijing Tiantan Hospital, Captial Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309708
- Sponsor's protocol ID
- HC-G-H-1722
- Status last verified
- Mar 2020
- First submitted
- 23 Dec 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Cntrolled, Multi-center Clinical Study on Efficacy and Safety of Infusion Therapy by Comparing Original Perfusor Line (Orange,Art No.8723017) With Original Perfusor Line (Black,Art No.8723010) in Pump Infusion.
- ClinicalTrials.gov ID
- NCT04309708
- Acronym / sponsor ID
- HC-G-H-1722
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- pump infusion, photodegradation, IV infusion therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 8 Sep 2019 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To verify the efficacy and safety of Original Perfusor Line (Art.No.8723017) in infusion therapy in Patients with light sensitive drug infusion.
Subjects who choose to use Original Perfusor Line for their planned infusion treatment (nimodipine injection) as per the study protocol will be enrolled. The 300 subjects will be 1:1 randomized into the experimental group or the control group, using Original Perfusor Line (Art.No. 8723017) connected with an injection pump for infusion treatment with nimodipine injection or Original Perfusor Line (Art.No.8723010) connected with an injection pump for infusion treatment with nimodipine injection, respectively.Use of both the test product and the control product will be in strict accordance with their package insert.
The primary endpoint is the percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications, visible catheter embolism, air embolism and micro embolism in the infusion system and the secondary endpoint is the quality assessment for the clinical application of the products,such as the percentage of products which are qualified for infusion administration including link and removal, transparence, and tenacity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Controlled, Parallel, Multi-center study
| Arm | Type | Receives |
|---|---|---|
| Original Perfusor Line(Art.No.8723017) | Experimental | Device: Nimodipine pump infusion |
| Original Perfusor Line(Art.No.8723010) | Active comparator | Device: Nimodipine pump infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years, all genders;
- Patients who will be treated plan to use injection pump for infusion treatment with nimodipine injection by infusion pump.
- Participated in this study voluntarily and signed informed consent form.
Key exclusion criteria (6 listed)
- Patients have contraindication on Nimodipine.
- Patients allergic to polyethylene (PE) material;
- Patients with aspartate transaminase(AST) and alanine transaminase(ALT) are 2 times higher than normal range, Serum creatinine(Scr) is 1.5 times higher than normal range.
- Patient with malignant tumor, pregnant or Lactation;
- Patients had participated in other clinical trials within 1 month and in parallel with other trials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimodipine pump infusionPatients with nimodipine pump infusion with pump infusion line and other infusion equipments | Device | Original Perfusor Line(Art.No.8723010), Original Perfusor Line(Art.No.8723017) |
Primary outcome
Infusion success rate
Time frame: 2 hours after infusion therapy completion
The percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications
1 secondary outcome
Product pass rate
Time frame: 2 hours after infusion therapy completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li ping Liu, Prof. principal investigator
Beijing Tiantan Hospital, Captial Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nimodipine pump infusion in people with Subarachnoid Hemorrhage, run by B. Braun Medical International Trading Company Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infusion success rate (time frame: 2 hours after infusion therapy completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.