Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Original Perfusor Line(Art.No.8723017) | Experimental |
| |
| Original Perfusor Line(Art.No.8723010) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimodipine pump infusion | Device | Patients with nimodipine pump infusion with pump infusion line and other infusion equipments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infusion success rate | The percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications | 2 hours after infusion therapy completion |
| Measure | Description | Time Frame |
|---|---|---|
| Product pass rate | 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. | 2 hours after infusion therapy completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Including tests of prothrombin time(PT) in second, activated partial thrombophastin time(APTT) in second and thrombin time(TT) in second |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Li ping Liu, Prof. | Beijing Tiantan Hospital, Captial Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China | ||
| Beijing Tiantan Hospital, Capital Medical University |
Not provided
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Randomized, Controlled, Parallel, Multi-center study
Not provided
Not provided
Not provided
| Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| white blood cell(WBC) | in 10^9/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Neutrophil(NEU) | in 10^9/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Red blood cell(RBC) | in 10^12/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Hemoglobin(HGB) | in g/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Hematocrit(HCT) | in percentage(%) | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Platelet(PLT) | in 10^9/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Blood urea nitrogen(BUN) | in mmoL/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Serum creatinine(SCr) | in umoL/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Urea | in mmoL/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Serum alanine transaminase(ALT) | in U/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Aspartate transaminase(AST) | in U/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Alkaline phosphatase(ALP) | in U/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| γ-glutamyl transpeptidase (GGT) | in U/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Total bilirubin(TBIL) | in umoL/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Total protein(TP) | in g/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Albumin(ALB) | in g/L | Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion |
| Beijing |
| Beijing Municipality |
| 100070 |
| China |
| Sanbo Brain Hospital, Captial Medical University | Beijing | Beijing Municipality | 100093 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |