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Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

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ClinicalTrials.gov Identifier: NCT02923830
Recruitment Status : Terminated (We stopped inserting BioFlo ports, no more patients to recruit)
First Posted : October 5, 2016
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Baker, TriHealth Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstruction; Catheter, Infusion Catheter (Vascular) Catheter; Complications (Indwelling Catheter) Other: Heparinized saline catheter flush Drug: Saline-only catheter flush Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Intervention group


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923830


Locations
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United States, Ohio
TriHealth Cancer Institute Good Samaritan Infusion Center at GSH
Cincinnati, Ohio, United States, 45220
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, 45242
TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot
Cincinnati, Ohio, United States, 45247
TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson
Cincinnati, Ohio, United States, 45255
TriHealth Cancer Institute Good Samaritan Infusion Center Butler County
Hamilton, Ohio, United States, 45011
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Sharon Sanker, RN, OCN TriHealth Cancer Institute
  Study Documents (Full-Text)

Documents provided by Rachel Baker, TriHealth Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] June 6, 2017

More Information
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Responsible Party: Rachel Baker, Nurse Researcher, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02923830    
Other Study ID Numbers: 15-117
First Posted: October 5, 2016    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study terminated