Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

Phase 4

Terminated

• Conditions: Catheter; Complications (Indwelling Catheter); Obstruction; Catheter, Infusion Catheter (Vascular)
• Interventions: Other: Heparinized saline catheter flush; Drug: Saline-only catheter flush

• Registration Number: NCT02923830
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-05
• Primary Completion: 2017-11
• Study Completion: 2019-03-26
• Results First Submitted: 2019-04-08
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-21
• Last Update Submitted: 2019-05-21
• Results First Posted: 2019-06-11
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Heparinized saline catheter flush	Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Intervention Group	Saline-only catheter flush	Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

TriHealth Cancer Institute Good Samaritan Infusion Center at GSH; 🇺🇸 Cincinnati, Ohio, United States

Ambulatory Treatment Center at Bethesda North TriHealth Hospital; 🇺🇸 Cincinnati, Ohio, United States

TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot; 🇺🇸 Cincinnati, Ohio, United States

TriHealth Cancer Institute Good Samaritan Infusion Center, Medicenter; 🇺🇸 Cincinnati, Ohio, United States

TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson; 🇺🇸 Cincinnati, Ohio, United States

TriHealth Cancer Institute Good Samaritan Infusion Center Butler County; 🇺🇸 Hamilton, Ohio, United States