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Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723187
Recruitment Status : Completed
First Posted : October 29, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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Brief Summary:
Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, Investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Condition or disease Intervention/treatment Phase
Cancer Other: normal saline Other: normal saline+heparin Not Applicable

Detailed Description:
A secure and easily feasible vascular access is crucial for oncology patients because of the therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related complication still remain and had to deal with. According to investigators clinical experience, investigators summarized a standard algorithm as a recommendation for intravenous sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %, respectively. However, catheter related infection and malfunction still could not be avoided. If patient was identified with these 2 complications, re-intervention is needed and cancer-related therapy has to be postpone. Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Cancer patients in need of chemotherapy
  2. Newly accepted Port-A Implant
  3. port maintenance:Catheter irrigation with 20 ml N/S,10 ml N/S sealing tube
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental group
use Normal saline
 Other: normal saline
experimental group use normal saline sealing tube
Active Comparator: comparator group
use Heparin
 Other: normal saline+heparin
normal saline+heparin(Currently, Regular used in hospital)


Outcome Measures
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Primary Outcome Measures :
  1. Port- A Catheter complication [ Time Frame: 1 year ]

    In the case of catheter-related complications, a complete biochemical and blood test will be performed on the patient.

    Will be tested for possible clotting factors, inflammatory index including CRP; procalcitonin; CBC / DC; PT / aPTT /Protein C/ protein S



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Volunteer with new Port-A inserted

Exclusion Criteria:

  • No
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723187


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Po-Jen Ko, MD Chang Gung Memorial Hospital
Principal Investigator: Chien-Hung Chiu, MD Chang Gung Memorial Hospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03723187    
Other Study ID Numbers: CGMH-IRB-104-9029B
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
intravenous port
port maintenancem
Additional relevant MeSH terms:
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Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action