- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723187
Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis
September 22, 2023 updated by: Chang Gung Memorial Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung memorial hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Volunteer with new Port-A inserted
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
use Normal saline
|
experimental group use normal saline sealing tube
|
Active Comparator: comparator group
use Heparin
|
normal saline+heparin(Currently, Regular used in hospital)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Po-Jen Ko, MD, Chang Gung memorial hospital
- Principal Investigator: Chien-Hung Chiu, MD, Chang Gung memorial hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
October 24, 2018
First Submitted That Met QC Criteria
October 25, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGMH-IRB-104-9029B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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