Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Subarachnoid Hemorrhage

Intervention / Treatment
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* Device: Nimodipine pump infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Controlled, Parallel, Multi-center study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Original Perfusor Line(Art.No.8723017)<br> | Device: Nimodipine pump infusion<br>* Patients with nimodipine pump infusion with pump infusion line and other infusion equipments<br>|
| Active Comparator: Original Perfusor Line(Art.No.8723010)<br> | Device: Nimodipine pump infusion<br>* Patients with nimodipine pump infusion with pump infusion line and other infusion equipments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infusion success rate | The percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications | 2 hours after infusion therapy completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours after infusion therapy completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pump infusion, photodegradation, IV infusion therapy