研究单位：[1]B. Braun Medical International Trading Company Ltd.[2]Beijing Tiantan Hospital, Captial Medical University[3]Xuanwu Hospital, Capital Medical University,Beijing, Beijing, China, 100000[4]Beijing Tiantan Hospital, Capital Medical University,Beijing, Beijing, China, 100070[5]Sanbo Brain Hospital, Captial Medical University,Beijing, Beijing, China, 100093[6]The Second Hospital of Hebei Medical University,Shijiazhuang, Hebei, China, 050000[7]Tianjin Medical University General Hospital,Tianjin, Tianjin, China, 300052
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.
