Maintaining Patency in Implanted Port Catheters

Catheter; Complications (Indwelling Catheter) Clinical Trial

Official title:

Maintaining Patency in Implanted Port Catheters With Saline Only Flushes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354118
• Other study ID #: 12135-12-079
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 17, 2021

Study information

• Verified date: September 2022
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: December 17, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter; Complications (Indwelling Catheter)
• Obstruction; Catheter, Infusion Catheter (Vascular)

Intervention

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

Locations

Country	Name	City	State
United States	Ambulatory Treatment Center at Bethesda North TriHealth Hospital	Cincinnati	Ohio
United States	TriHealth Cancer Institute Good Samaritan Infusion Center at GSH	Cincinnati	Ohio
United States	TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson	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	UC Health Barrett Infusion Center	Cincinnati	Ohio
United States	TriHealth Cancer Institute Good Samaritan Infusion Center Butler County	Hamilton	Ohio
United States	McCullough Hyde Memorial Hospital Infusion Center	Oxford	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With First Complete Occlusion Within 1 Year	Number of participants who had a first complete occlusion (Blockage) within 1 year	baseline to 1 year
Primary	Number of Participants With First Partial Occlusion Within 1 Year	Number of Participants with First Partial Occlusion (Blockage) within 1 year	baseline to 1 year
Primary	Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year	Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year	baseline to 1 year
Secondary	Number of Participants With First Complete or Partial Occlusion Within 1 Year	Number of Participants with either a First Complete or Partial Occlusion (Blockage) within 1 year	baseline to 1 year
Secondary	Number of Participants With HIT Within 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