Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

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.

Study Overview

• Status: Terminated
• Conditions: Obstruction; Catheter, Infusion Catheter (Vascular); Catheter; Complications (Indwelling Catheter)
• Intervention / Treatment: Other: Heparinized saline catheter flush; Drug: Saline-only catheter flush

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth Cancer Institute Good Samaritan Infusion Center at GSH
    • Cincinnati, Ohio, United States, 45242
      • Ambulatory Treatment Center at Bethesda North TriHealth Hospital
    • Cincinnati, Ohio, United States, 45242
      • TriHealth Cancer Institute Good Samaritan Infusion Center, Medicenter
    • Cincinnati, Ohio, United States, 45247
      • TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot
    • Cincinnati, Ohio, United States, 45255
      • TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson
    • Hamilton, Ohio, United States, 45011
      • TriHealth Cancer Institute Good Samaritan Infusion Center Butler County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months	Other: Heparinized saline catheter flush; The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months; Other Names: Control group
Experimental: Intervention Group; Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.	Drug: Saline-only catheter flush; The intervention group will have their port catheters flushed with saline only.; Other Names: Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Occurrence of First Complete Occlusion (Blockage)	Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded.	baseline to 1 year
Number of Participants With Occurrence of First Partial Occlusion (Blockage)	Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded.	baseline to 1 year
Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion	Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded.	baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complete or Partial Occlusions	The number of complete or partial occlusions after the first occurrence will be recorded.	baseline to 1 year
Number of Days Catheter Remains Patent (Unobstructed)	The number of days from study enrollment to the first partial or complete occlusion and the number of days between incidences of partial or complete occlusion will be recorded.	baseline to 1 year
Central Line-Associated Blood Stream Infection (CLABSI)	Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded.	baseline to 1 year
Heparin-related Complication	Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.	baseline to 1 year

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Sharon Sanker, RN, OCN, TriHealth Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 15-117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study terminated