NCT04309708

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: B. Braun Medical International Trading Company Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Nimodipine pump infusion	Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-09-06
• Completion: 2019-09-08
• First posted: 2020-03-16
• Last updated: 2020-03-16

Locations

5 sites across 1 country: China