Clinical trial NCT02923830: Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Official title: Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstruction; Catheter, Infusion Catheter (Vascular)
Catheter; Complications (Indwelling Catheter)
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo 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 BioFlo 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 a BioFlo implanted port in place less than one (1) year
* Evidence of a patent BioFlo port catheter prior to enrollment in the study
* Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo 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 BioFlo 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 meet one or more of the inclusion criteria

Primary outcomes:
measure: Number of Participants With Occurrence of First Complete Occlusion (Blockage)
timeFrame: baseline to 1 year
measure: Number of Participants With Occurrence of First Partial Occlusion (Blockage)
timeFrame: baseline to 1 year
measure: Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion
timeFrame: baseline to 1 year
Secondary outcomes:
measure: Number of Complete or Partial Occlusions
timeFrame: baseline to 1 year
measure: Number of Days Catheter Remains Patent (Unobstructed)
timeFrame: baseline to 1 year
measure: Central Line-Associated Blood Stream Infection (CLABSI)
timeFrame: baseline to 1 year
measure: Heparin-related Complication
timeFrame: baseline to 1 year
Other outcomes:
Locations:
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
Study officials:
affiliation: TriHealth Cancer Institute
name: Sharon Sanker, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References: