NCT03723187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

September 25, 2023

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

October 24, 2018

Last Update Submit

September 22, 2023

Conditions

Cancer

Keywords

intravenous portport maintenancem

Outcome Measures

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

    1 year

Study Arms (2)

experimental group

EXPERIMENTAL

use Normal saline

Other: normal saline

comparator group

ACTIVE COMPARATOR

use Heparin

Other: normal saline+heparin

Interventions

normal salineOTHER

experimental group use normal saline sealing tube

experimental group
normal saline+heparinOTHER

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

comparator group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer with new Port-A inserted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Po-Jen Ko, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Chien-Hung Chiu, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 29, 2018

Study Start

August 1, 2016

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 25, 2023

Record last verified: 2019-07

Locations

TW(1)