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

Subarachnoid Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309708
• Other study ID #: HC-G-H-1722
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: September 8, 2019

Study information

• Verified date: March 2020
• Source: B. Braun Medical International Trading Company Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 8, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Nimodipine pump infusion
Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Sanbo Brain Hospital, Captial Medical University	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical International Trading Company Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Blood coagulation Test	Including tests of prothrombin time(PT) in second, activated partial thrombophastin time(APTT) in second and thrombin time(TT) in second	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	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
Other	Neutrophil(NEU)	in 10^9/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	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
Other	Hemoglobin(HGB)	in g/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Hematocrit(HCT)	in percentage(%)	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Platelet(PLT)	in 10^9/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	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
Other	Serum creatinine(SCr)	in umoL/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Urea	in mmoL/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	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
Other	Aspartate transaminase(AST)	in U/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Alkaline phosphatase(ALP)	in U/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	?-glutamyl transpeptidase (GGT)	in U/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Total bilirubin(TBIL)	in umoL/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Total protein(TP)	in g/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Other	Albumin(ALB)	in g/L	Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion
Primary	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
Secondary	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