Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

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

Intervention / Treatment
-----------------
* Other: Heparinized saline catheter flush
* Drug: Saline-only catheter flush


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months | Other: Heparinized saline catheter flush<br>* The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months<br>* Other names: Control group;|
| Experimental: Intervention Group<br>Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. | Drug: Saline-only catheter flush<br>* The intervention group will have their port catheters flushed with saline only.<br>* Other names: Intervention group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Complete or Partial Occlusions | The number of complete or partial occlusions after the first occurrence will be recorded. | baseline to 1 year | 
| 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 | 
| 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 | 
| 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 |