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

NCT04309708 | Completed DMC

• 1 other identifier: HC-G-H-1722
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Subarachnoid Hemorrhage

Keywords

pump infusion; photodegradation; IV infusion therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Product pass rate

  2 hours after infusion therapy completion

Other Outcomes (18)

• 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

• white blood cell(WBC)

  Day -7(At least 7days before infusion therapy), Day 0 (infusion therapy) , 2 hours after infusion therapy completion

Study Arms (2)

Original Perfusor Line(Art.No.8723017)

EXPERIMENTAL

Device: Nimodipine pump infusion

Original Perfusor Line(Art.No.8723010)

ACTIVE COMPARATOR

Device: Nimodipine pump infusion

Interventions

Nimodipine pump infusion DEVICE

Patients with nimodipine pump infusion with pump infusion line and other infusion equipments

Original Perfusor Line(Art.No.8723010); Original Perfusor Line(Art.No.8723017)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• B. Braun Medical International Trading Company Ltd.: lead

Study Sites (5)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Sanbo Brain Hospital, Captial Medical University

Beijing, Beijing Municipality, 100093, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li ping Liu, Prof.

  Beijing Tiantan Hospital, Captial Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Controlled, Parallel, Multi-center study

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: March 16, 2020
• Study Start: May 1, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 8, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

CN (5)