Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

Catheter; Complications (Indwelling Catheter) Clinical Trial

Official title:

Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02923830
• Other study ID #: 15-117
• Status: Terminated
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: March 26, 2019

Study information

• Verified date: May 2019
• 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 26, 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Drug:
• 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	TriHealth Cancer Institute Good Samaritan Infusion Center Butler County	Hamilton	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 Occurrence of First Complete Occlusion (Blockage)	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
Primary	Number of Participants With Occurrence of First Partial Occlusion (Blockage)	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
Primary	Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion	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	Number of Complete or Partial Occlusions	The number of complete or partial occlusions after the first occurrence will be recorded.	baseline to 1 year
Secondary	Number of Days Catheter Remains Patent (Unobstructed)	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
Secondary	Central Line-Associated Blood Stream Infection (CLABSI)	Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded.	baseline to 1 year
Secondary	Heparin-related Complication	Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.	baseline to 1 year