Maintaining Patency in Implanted Port Catheters

Study Overview
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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 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
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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 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
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Maintaining Patency in Implanted Port Catheters With Saline Only Flushes

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

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
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>|
| Experimental: Intervention Group<br>Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. | Other: Saline-only catheter flush<br>* The intervention group will have their port catheters flushed with saline only.<br>|

What is the study measuring?
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Primary Outcome Measures

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

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