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

B. Braun

Status

Completed

Conditions

Subarachnoid Hemorrhage

Treatments

Device: Nimodipine pump infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT04309708

HC-G-H-1722

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.