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Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12

Primary Purpose

Maintenance of Implanted Port Devices

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced IPD Flush Schedule
Standard IPD Flush Schedule
Sponsored by
Essentia Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maintenance of Implanted Port Devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device.
  • No planned clinical visits for at least 12 weeks.
  • No planned need to access Implanted Port Device within next 12 weeks outside of routine flushing. Potential reasons to access can include but are not limited to lab draw, infusion, IV contrast.
  • No planned removal of IPD within 12 weeks of registration.
  • No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration.
  • Patient Implanted Port Device with documented blood return ≤ 14 days of registration.
  • Ability to read and speak English.
  • Able to give informed consent.

Exclusion Criteria:

  • Allergy to heparin
  • Vulnerable populations: pregnant women, prisoners, mentally handicapped.

Sites / Locations

  • Mayo Clinic Health System - Albert LeaRecruiting
  • Essentia Health St. Joseph's Medical CenterRecruiting
  • Essentia Health Deer River ClinicRecruiting
  • Essentia Health St Mary's Detroit Lakes ClinicRecruiting
  • Essentia Health Duluth ClinicRecruiting
  • Essentia Health FosstonRecruiting
  • Essentia Health Hibbing ClinicRecruiting
  • Mayo Clinic Health System - MankatoRecruiting
  • Monticello Cancer centerRecruiting
  • Essentia Health Park RapidsRecruiting
  • Essentia Health SandstoneRecruiting
  • Essentia Health Virginia ClinicRecruiting
  • Essentia Health FargoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

4-week IPD Flushing Schedule

12-week IPD Flushing Schedule

Arm Description

IPD standard maintenance flushes and port assessments every 4 weeks.

IPD standard maintenance flushes and port assessments every 12 weeks.

Outcomes

Primary Outcome Measures

Rate of IPD patency
IPD patency without major complication

Secondary Outcome Measures

Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.
Rate of IPD patency during long term follow-up
Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.
Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events
Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes
Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status.
Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes
Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale.
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events

Full Information

First Posted
June 24, 2022
Last Updated
January 6, 2023
Sponsor
Essentia Health
Collaborators
Minnesota Cancer Clinical Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT05454189
Brief Title
Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12
Official Title
A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essentia Health
Collaborators
Minnesota Cancer Clinical Trials Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Implanted port devices (IPD) play an essential role in the safe administration of cancer treatments by providing a device to safely administer caustic chemotherapy agents. The current recommended frequency of flushing the IPD per manufacturers guidelines is every 4-6 weeks. The purpose of this study is to find out if extending IPD flushes to every 12 weeks is safe and if it is just as effective as every 4 week flushing.
Detailed Description
After being informed about the study and potential risks, all participants giving written informed consent will complete port specific histories, assessments and questionnaires within 14 days prior to registration. Eligible, consented participants will be registered to the study and randomized to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for an initial 12 week interval. If study participants agree to the continuation portion of the study, they will continue to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for up to an additional three 12 week cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maintenance of Implanted Port Devices

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a prospective, randomized study to determine the non-inferiority of every 12 week IPD flushes compared to every 4 week flushes in participants on an IPD maintenance flush schedule.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4-week IPD Flushing Schedule
Arm Type
Active Comparator
Arm Description
IPD standard maintenance flushes and port assessments every 4 weeks.
Arm Title
12-week IPD Flushing Schedule
Arm Type
Experimental
Arm Description
IPD standard maintenance flushes and port assessments every 12 weeks.
Intervention Type
Device
Intervention Name(s)
Reduced IPD Flush Schedule
Intervention Description
IPD flush every 12 weeks
Intervention Type
Device
Intervention Name(s)
Standard IPD Flush Schedule
Intervention Description
IPD flush every 4 weeks
Primary Outcome Measure Information:
Title
Rate of IPD patency
Description
IPD patency without major complication
Time Frame
12 weeks post randomization
Secondary Outcome Measure Information:
Title
Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.
Description
Rate of IPD patency during long term follow-up
Time Frame
Up to 48 weeks post randomization
Title
Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.
Description
Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events
Time Frame
Up to 48 weeks post randomization
Title
Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes
Description
Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status.
Time Frame
Up to 48 weeks post randomization
Title
Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes
Description
Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale.
Time Frame
Up to 48 weeks post randomization
Title
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.
Description
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events
Time Frame
Up to 48 weeks post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device. No planned clinical visits for at least 12 weeks. No planned need to access Implanted Port Device within next 12 weeks outside of routine flushing. Potential reasons to access can include but are not limited to lab draw, infusion, IV contrast. No planned removal of IPD within 12 weeks of registration. No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration. Patient Implanted Port Device with documented blood return ≤ 14 days of registration. Ability to read and speak English. Able to give informed consent. Exclusion Criteria: Allergy to heparin Vulnerable populations: pregnant women, prisoners, mentally handicapped.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bret Friday, MD, PhD
Phone
218-786-3625
Email
bret.friday@essentiahealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tammie Mlodozyniec
Phone
218-786-1018
Email
tammie.mlodozyniec@essentiahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Friday, MD, PhD
Organizational Affiliation
Essentia Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System - Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina Hanna, MD
Phone
612-624-2620
Email
ccinfo@umn.edu
Facility Name
Essentia Health St. Joseph's Medical Center
City
Brainerd
State/Province
Minnesota
ZIP/Postal Code
56401
Country
United States
Individual Site Status
Recruiting
Facility Name
Essentia Health Deer River Clinic
City
Deer River
State/Province
Minnesota
ZIP/Postal Code
56636
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Essentia Health St Mary's Detroit Lakes Clinic
City
Detroit Lakes
State/Province
Minnesota
ZIP/Postal Code
56501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Essentia Health Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Phone
218-786-1018
Email
tammie.mlodozyniec@essentiahealth.org
First Name & Middle Initial & Last Name & Degree
Bret Friday, MD, PhD
Facility Name
Essentia Health Fosston
City
Fosston
State/Province
Minnesota
ZIP/Postal Code
56542
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Essentia Health Hibbing Clinic
City
Hibbing
State/Province
Minnesota
ZIP/Postal Code
55746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Mayo Clinic Health System - Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Thome
Phone
612-624-2620
Email
ccinfo@umn.edu
Facility Name
Monticello Cancer center
City
Monticello
State/Province
Minnesota
ZIP/Postal Code
55362
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Ji, MD
Phone
612-624-2620
Email
ccinfo@umn.edu
Facility Name
Essentia Health Park Rapids
City
Park Rapids
State/Province
Minnesota
ZIP/Postal Code
56470
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Essentia Health Sandstone
City
Sandstone
State/Province
Minnesota
ZIP/Postal Code
55072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Essentia Health Virginia Clinic
City
Virginia
State/Province
Minnesota
ZIP/Postal Code
55792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammie Mlodozyniec
Facility Name
Essentia Health Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol, statistical plan and consent form will be available on request. Data will be available on aggregate level; data will be deidentified, the full dataset and statistical code will be available upon request
IPD Sharing Time Frame
6 months after study completion and for 36 months
IPD Sharing Access Criteria
A full description of the intended use of the data must be sent to the Project Direct for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.

Learn more about this trial

Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12

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