Subarachnoid Hemorrhage Clinical Trial
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.
n/a
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