Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-03-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Heparinized saline catheter flush

Intervention Type OTHER

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

Intervention Group

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

Group Type EXPERIMENTAL

Saline-only catheter flush

Intervention Type DRUG

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

Interventions

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Heparinized saline catheter flush

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

Intervention Type OTHER

Saline-only catheter flush

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

Intervention Type DRUG

Other Intervention Names

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Control group Intervention group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No