Status:
COMPLETED
Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy
Lead Sponsor:
B. Braun Medical International Trading Company Ltd.
Conditions:
Subarachnoid Hemorrhage
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04309708
Start Date
May 1 2018
End Date
September 8 2019
Last Update
March 16 2020
Active Locations (5)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
3
Sanbo Brain Hospital, Captial Medical University
Beijing, Beijing Municipality, China, 100093
4
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000