Clinical trial NCT04309708: Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy
Official title: A Prospective, Randomized, Cntrolled, Multi-center Clinical Study on Efficacy and Safety of Infusion Therapy by Comparing Original Perfusor Line (Orange,Art No.8723017) With Original Perfusor Line (Black,Art No.8723010) in Pump Infusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: pump infusion
photodegradation
IV infusion therapy
Lead sponsor: B. Braun Medical International Trading Company Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Controlled, Parallel, Multi-center study
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Infusion success rate
timeFrame: 2 hours after infusion therapy completion
Secondary outcomes:
measure: Product pass rate
timeFrame: 2 hours after infusion therapy completion
Other outcomes:
measure: Incidence of Adverse Events/Serious Adverse Events during treatment
timeFrame: Day -7 (At least 7days before infusion therapy) , Day 0 (infusion therapy), 2 hours after infusion therapy completion
measure: Blood coagulation Test
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: white blood cell(WBC)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Neutrophil(NEU)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Red blood cell(RBC)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Hemoglobin(HGB)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Hematocrit(HCT)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Platelet(PLT)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Blood urea nitrogen(BUN)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Serum creatinine(SCr)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Urea
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Serum alanine transaminase(ALT)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Aspartate transaminase(AST)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Alkaline phosphatase(ALP)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: γ-glutamyl transpeptidase (GGT)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Total bilirubin(TBIL)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Total protein(TP)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
measure: Albumin(ALB)
timeFrame: Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Sanbo Brain Hospital, Captial Medical University
state: Beijing
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Beijing Tiantan Hospital, Captial Medical University
name: Li ping Liu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: