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Completed

NCT Number: NCT04309708

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nimodipine pump infusion

Device

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

Primary outcomes

  1. Infusion success rate

    Time frame: 2 hours after infusion therapy completion

    The percentage of products which successful infuse fluids or medications into patient's circulatory system without leakage of fluids or medications

Secondary outcomes

  1. Product pass rate

    Time frame: 2 hours after infusion therapy completion

    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.

Other outcomes

  1. Incidence of Adverse Events/Serious Adverse Events during treatment

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

  2. Blood coagulation Test

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

    Including tests of prothrombin time(PT) in second, activated partial thrombophastin time(APTT) in second and thrombin time(TT) in second

  3. white blood cell(WBC)

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

    in 10^9/L

  4. Neutrophil(NEU)

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

    in 10^9/L

  5. Red blood cell(RBC)

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

    in 10^12/L

  6. Hemoglobin(HGB)

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

    in g/L

  7. Hematocrit(HCT)

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

    in percentage(%)

  8. Platelet(PLT)

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

    in 10^9/L

  9. Blood urea nitrogen(BUN)

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

    in mmoL/L

  10. Serum creatinine(SCr)

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

    in umoL/L

  11. Urea

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

    in mmoL/L

  12. Serum alanine transaminase(ALT)

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

    in U/L

  13. Aspartate transaminase(AST)

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

    in U/L

  14. Alkaline phosphatase(ALP)

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

    in U/L

  15. γ-glutamyl transpeptidase (GGT)

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

    in U/L

  16. Total bilirubin(TBIL)

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

    in umoL/L

  17. Total protein(TP)

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

    in g/L

  18. Albumin(ALB)

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

    in g/L

Sponsors and collaborators

Lead sponsor

B. Braun Medical International Trading Company Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 16, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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