Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

TriHealth

Status and phase: Terminated; Phase 4

Conditions: Catheter; Complications (Indwelling Catheter); Obstruction; Catheter, Infusion Catheter (Vascular)

Treatments: Other: Heparinized saline catheter flush; Drug: Saline-only catheter flush

Study type: Interventional

Funder types: Other

Identifiers

NCT02923830

15-117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Heparinized saline catheter flush

Intervention Group

Experimental group

Description:

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

Treatment:

Drug: Saline-only catheter flush