Clinical trial NCT02354118: Maintaining Patency in Implanted Port Catheters
Official title: Maintaining Patency in Implanted Port Catheters With Saline Only Flushes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstruction; Catheter, Infusion Catheter (Vascular)
Catheter; Complications (Indwelling Catheter)
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.

Detailed description: The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline. These complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.

Eligibility criteria: Inclusion Criteria:

* Able to read and understand English
* Has an implanted port in place less than one (1) year
* Evidence of a patent (unobstructed) port catheter prior to enrollment in the study
* Is receiving active treatment (i.e., receiving a therapeutic drug through the implanted port)
* Current treatment protocol projected to continue for a minimum of three (3) months
* Anticipates receiving care at the identified centers for 12 months following enrollment in the study
* Does not receive care of implanted port at any other facility

Exclusion Criteria:

* Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin
* Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin)
* Does not have a BioFlo port (heparinized port)
* Does not meet one or more of the inclusion criteria

Primary outcomes:
measure: Number of Participants With First Complete Occlusion Within 1 Year
timeFrame: baseline to 1 year
measure: Number of Participants With First Partial Occlusion Within 1 Year
timeFrame: baseline to 1 year
measure: Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
timeFrame: baseline to 1 year
Secondary outcomes:
measure: Number of Participants With First Complete or Partial Occlusion Within 1 Year
timeFrame: baseline to 1 year
measure: Number of Participants With HIT Within 1 Year
timeFrame: baseline to 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: UC Health Barrett Infusion Center
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute Good Samaritan Infusion Center at GSH
state: Ohio
city: Cincinnati
country: United States
facility: Ambulatory Treatment Center at Bethesda North TriHealth Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute Good Samaritan Infusion Center, Medicenter
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson
state: Ohio
city: Hamilton
country: United States
facility: TriHealth Cancer Institute Good Samaritan Infusion Center Butler County
state: Ohio
city: Oxford
country: United States
facility: McCullough Hyde Memorial Hospital Infusion Center
state: Ohio
Study officials:
affiliation: TriHealth Cancer Institute
name: Sarah Pelgen, BSN, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References: