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

NCT04309708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-03-16

No results posted yet for this study

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. 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

Interventions

DEVICE

Nimodipine pump infusion

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

Sponsors & Collaborators

  • B. Braun Medical International Trading Company Ltd.

    lead INDUSTRY

Principal Investigators

  • Li ping Liu, Prof. · Beijing Tiantan Hospital, Captial Medical University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-09-06
Completion
2019-09-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309708 on ClinicalTrials.gov