Clinical trial NCT05454189: 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
Overall status: RECRUITING
Phase: NA
Conditions: Maintenance of Implanted Port Devices
Lead sponsor: Essentia Health
Sponsor class: OTHER
Collaborators: name: Minnesota Cancer Clinical Trials Network
First posted: 2022-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Rate of IPD patency
timeFrame: 12 weeks post randomization
Secondary outcomes:
measure: Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.
timeFrame: Up to 48 weeks post randomization
measure: Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.
timeFrame: Up to 48 weeks post randomization
measure: Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes
timeFrame: Up to 48 weeks post randomization
measure: Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes
timeFrame: Up to 48 weeks post randomization
measure: Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.
timeFrame: Up to 48 weeks post randomization
Other outcomes:
Locations:
city: Albert Lea
country: United States
facility: Mayo Clinic Health System - Albert Lea
state: Minnesota
city: Brainerd
country: United States
facility: Essentia Health St. Joseph's Medical Center
state: Minnesota
city: Deer River
country: United States
facility: Essentia Health Deer River Clinic
state: Minnesota
city: Detroit Lakes
country: United States
facility: Essentia Health St Mary's Detroit Lakes Clinic
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Duluth Clinic
state: Minnesota
city: Fosston
country: United States
facility: Essentia Health Fosston
state: Minnesota
city: Grand Rapids
country: United States
facility: Fairview Grand Itasca Clinic & Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Essentia Health Hibbing Clinic
state: Minnesota
city: Hibbing
country: United States
facility: Fairview Range Medical Center
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health System - Mankato
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer center
state: Minnesota
city: Park Rapids
country: United States
facility: Essentia Health Park Rapids
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Sandstone
country: United States
facility: Essentia Health Sandstone
state: Minnesota
city: Virginia
country: United States
facility: Essentia Health Virginia Clinic
state: Minnesota
city: Worthington
country: United States
facility: Sanford Worthington Medical Center
state: Minnesota
city: Fargo
country: United States
facility: Essentia Health Fargo
state: North Dakota
Study officials:
affiliation: Essentia Health
name: Bret Friday, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: