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Completed

NCT Number: NCT02354118

Maintaining Patency in Implanted Port Catheters

The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to read and understand English
  • Has an implanted port in place less than one (1) year
  • Evidence of a patent (unobstructed) port catheter prior to enrollment in the study
  • Is receiving active treatment (i.e., receiving a therapeutic drug through the 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 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 have a BioFlo port (heparinized port)
  • Does not meet one or more of the inclusion criteria

Treatment and study plan

Heparinized saline catheter flush

Other

The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months

Saline-only catheter flush

Other

The intervention group will have their port catheters flushed with saline only.

Primary outcomes

  1. Number of Participants With First Complete Occlusion Within 1 Year

    Time frame: baseline to 1 year

    Number of participants who had a first complete occlusion (Blockage) within 1 year

  2. Number of Participants With First Partial Occlusion Within 1 Year

    Time frame: baseline to 1 year

    Number of Participants with First Partial Occlusion (Blockage) within 1 year

  3. Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year

    Time frame: baseline to 1 year

    Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year

Secondary outcomes

  1. Number of Participants With First Complete or Partial Occlusion Within 1 Year

    Time frame: baseline to 1 year

    Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year

  2. Number of Participants With HIT Within 1 Year

    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.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Maintaining Patency in Implanted Port Catheters With Saline Only Flushes

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2015
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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