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

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.

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage
• Intervention / Treatment: Device: Nimodipine pump infusion

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University
    • Beijing, Beijing, China, 100000
      • Xuanwu Hospital, Capital Medical University
    • Beijing, Beijing, China, 100093
      • Sanbo Brain Hospital, Captial Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Original Perfusor Line(Art.No.8723017)	Device: Nimodipine pump infusion; Patients with nimodipine pump infusion with pump infusion line and other infusion equipments
Active Comparator: Original Perfusor Line(Art.No.8723010)	Device: Nimodipine pump infusion; Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: B. Braun Medical International Trading Company Ltd.
• Investigators: Principal Investigator: Li ping Liu, Prof., Beijing Tiantan Hospital, Captial Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): September 8, 2019

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pump infusion; photodegradation; IV infusion therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Nimodipine
• Other Study ID Numbers: HC-G-H-1722

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No