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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-09-08

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.

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Detailed Description

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Controlled, Parallel, Multi-center study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Original Perfusor Line(Art.No.8723017)

Group Type EXPERIMENTAL

Nimodipine pump infusion

Intervention Type DEVICE

Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

Original Perfusor Line(Art.No.8723010)

Group Type ACTIVE_COMPARATOR

Nimodipine pump infusion

Intervention Type DEVICE

Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

Interventions

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Nimodipine pump infusion

Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No