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CompletedNCT03723187Updated Sep 25, 2023

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

An interventional study of normal saline and normal saline+heparin in Cancer, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Aug 2016, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer

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Keywords

  • intravenous port
  • port maintenancem
03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 38 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Volunteer with new Port-A inserted

Exclusion criteria

Exclusion Criteria:

  • No
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    experimental group

    use Normal saline

    Other: normal saline

  • Active comparator
    comparator group

    use Heparin

    Other: normal saline+heparin

Interventions

  • Othernormal saline

    experimental group use normal saline sealing tube

  • Othernormal saline+heparin

    normal saline+heparin(Currently, Regular used in hospital)

06

What researchers measure

Primary outcomes

  1. Port- A Catheter complication

    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

    Time frame: 1 year

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03723187
Responsible party
Sponsor
First posted
Oct 29, 2018
Start date
Aug 1, 2016
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Sep 25, 2023

Study contacts

Po-Jen Ko, MD
principal investigator · Chang Gung Memorial Hospital
Chien-Hung Chiu, MD
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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