Subarachnoid Hemorrhage
Conditions
Keywords
pump infusion, photodegradation, IV infusion therapy
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 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.
Interventions
DEVICENimodipine pump infusion
Patients with nimodipine pump infusion with pump infusion line and other infusion equipments
Sponsors
B. Braun Medical International Trading Company Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, Controlled, Parallel, Multi-center study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infusion success rate | 2 hours after infusion therapy completion | The percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product pass rate | 2 hours after infusion therapy completion | percentage of the quantity of products that pass the evaluation in the sum of products that pass the evaluation and products that fail the evaluation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events/Serious Adverse Events during treatment | Day -7 (At least 7days before infusion therapy) , Day 0 (infusion therapy), 2 hours after infusion therapy completion | — |
| Blood coagulation Test | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | Including tests of prothrombin time(PT) in second, activated partial thrombophastin time(APTT) in second and thrombin time(TT) in second |
| white blood cell(WBC) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in 10\^9/L |
| Neutrophil(NEU) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in 10\^9/L |
| Red blood cell(RBC) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in 10\^12/L |
| Hemoglobin(HGB) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in g/L |
| Hematocrit(HCT) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in percentage(%) |
| Platelet(PLT) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in 10\^9/L |
| Blood urea nitrogen(BUN) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in mmoL/L |
| Serum creatinine(SCr) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in umoL/L |
| Serum alanine transaminase(ALT) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in U/L |
| Aspartate transaminase(AST) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in U/L |
| Alkaline phosphatase(ALP) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in U/L |
| γ-glutamyl transpeptidase (GGT) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in U/L |
| Total bilirubin(TBIL) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in umoL/L |
| Total protein(TP) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in g/L |
| Albumin(ALB) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in g/L |
| Urea | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion | in mmoL/L |
Countries
China
Outcome results
None listed