Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

May 21, 2019 updated by: Rachel Baker, TriHealth Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Occurrence of First Complete Occlusion (Blockage)
Time Frame: 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.
baseline to 1 year
Number of Participants With Occurrence of First Partial Occlusion (Blockage)
Time Frame: 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.
baseline to 1 year
Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion
Time Frame: 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.
baseline to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Complete or Partial Occlusions
Time Frame: baseline to 1 year
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)
Time Frame: 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.
baseline to 1 year
Central Line-Associated Blood Stream Infection (CLABSI)
Time Frame: baseline to 1 year
Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded.
baseline to 1 year
Heparin-related Complication
Time Frame: baseline to 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TriHealth Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharon Sanker, RN, OCN, TriHealth Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study terminated

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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