Maintaining Patency in Implanted Port Catheters

Not Applicable

Completed

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

• Registration Number: NCT02354118
• 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 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 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: 2013-01
• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Primary Completion: 2021-12-11
• Study Completion: 2021-12-17
• Results First Submitted: 2022-01-24
• Results First Submitted QC: 2022-08-18
• Status Verified: 2022-09
• Results First Posted: 2022-09-14
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Saline-only catheter flush	Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
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

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year	baseline to 1 year	Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year
Number of Participants With First Complete Occlusion Within 1 Year	baseline to 1 year	Number of participants who had a first complete occlusion (Blockage) within 1 year
Number of Participants With First Partial Occlusion Within 1 Year	baseline to 1 year	Number of Participants with First Partial Occlusion (Blockage) within 1 year

Secondary Outcome Measures

Name	Time	Method
Number of Participants With HIT Within 1 Year	baseline to 1 year	Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.
Number of Participants With First Complete or Partial Occlusion Within 1 Year	baseline to 1 year	Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year

Trial Locations

Locations (8)

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

McCullough Hyde Memorial Hospital Infusion Center; 🇺🇸 Oxford, Ohio, United States

UC Health Barrett Infusion Center; 🇺🇸 Cincinnati, Ohio, United States

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

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

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

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

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