Clinical trial NCT02923830
Conditions: Obstruction; Catheter, Infusion Catheter (Vascular) Catheter; Complications (Indwelling Catheter)
Sponsor: TriHealth Inc.
Start date: 2016-04-01; Completion date: 2019-03-26
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months arm 2: Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only.
Interventions: intervention 1: Heparinized saline catheter flush intervention 2: Saline-only catheter flush
Intervention descriptions: intervention 1: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months intervention 2: The intervention group will have their port catheters flushed with saline only.

Protocol documents:
Prot_SAP_000.pdf: 
 Maintaining Patency in BioFlo Ports …..1 
Protocol.docx 
TriHealth Research Protocol Outline 
 
Date 
June 6, 2017 
Title 
Maintaining Patency in BioFlo Implanted Port Catheters with 
Saline Only Flushes 
Principal Investigator 
Sharon Sanker, RN, OCN 
Sub-Investigators 
Sarah Pelgen, BSN, RN, OCN , Ranga Brahmamdam,  MD,   
 
Hatton # 
15-117 
 
 
Purpose of Study: In this institution, the majority of cancer patients have implanted port 
catheters. Maintenance of implanted port catheters is critical for the delivery of safe and effective 
care for cancer patients who need dedicated venous access for purposes of blood draws, blood 
product infusions, intravenous medications, intravenous fluids, and/or antineoplastic therapy. 
One of the most common complications of implanted port catheters is occlusion. The primary 
cause of catheter occlusion is the formation of a thrombus within or surrounding the catheter 
(McGee & Gould, 2003). The formation of a thrombus starts as a fibrin sleeve or sheath 
consisting of platelets and fibrin. Routine flushing of implanted port catheters is conducted as a 
measure to prevent the formation of a fibrin sleeve.  
 
According to the TriHealth Nursing Policy and Procedure Intravenous Site Guidelines, an 
implanted port catheter should be flushed with 20 ml of normal saline after IV medication, 
blood, or blood draws. Heparinized saline in the amount of 5 mL (concentration 100 units/mL) 
should be used as a final flush when no IV fluids are running and before de-accessing.  
However, routine use of heparinized saline flushes has been known to result in heparin induced 
thrombocytopenia (HIT), an immune reaction to heparin that can have serious consequences 
(Cooney, 2006). Additionally, heparin does not have fibrinolytic activity; therefore, it will not 
lyse existing clots (Heparin Lock Flush Solution). It is recommended that the use of heparin be 
avoided or minimized whenever possible (Cooney, 2006).  
 
While evidence in the literature is scant, there is no clear consensus on the need and efficacy of 
heparinized saline as the solution for maintaining patency in implanted port catheters (Camp-
Sorrell, 2010). Therefore, a nursing research study to determine the safest and most effective 
flushing solution(s) for maintaining patency in implanted port catheters began in the TriHealth 
Infusion Centers in January of 2013. This is an ongoing non-inferiority study using a randomized 
controlled trial methodology to compare the efficacy to a 20 mL normal saline flush with a 20 
mL normal saline flush followed by a 5 mL heparinized saline (100 units/mL), the standard of 
care at TriHealth. As of October 30, 2015, 135 of 396 target population have been enrolled in the 
study.   
 
A few months ago, the BioFlo Port with Endexo Technology (referred to hereafter as the BioFlo 
Port) was introduced in some of the TriHealth facilities inserting implanted port catheters and 
providing care to patients with implanted port catheters.  The catheter in the BioFlo Port contains 
a “permanent and non-eluting polymer that is ‘blended’ into the polyurethane from which the 
catheter is made” (Navilyst Medical, Inc.,  2014, pg. 3). Navilyst Medical, Inc., the manufacturer 


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Protocol.docx 
of the BioFlo Port claims that this port has  96% less thrombus accumulation on the surface of 
the catheter as compared to the non-coated conventional port catheters. However, the data 
supporting this claim is from in-vitro studies. Materials from Navilyst Medical, Inc., state that 
this technology provides a saline-only flushing option but does not specifically state that use of 
heparinized saline in the flushing protocol is not needed. Additionally, no studies on human 
patients have been conducted evaluating the rate of occlusions among patients with a BioFlo Port 
catheter. The implanted port-catheters in use by patients in the study currently in progress within 
the TriHealth Infusion Centers are made of a different material, thus the efficacy of flushing 
solutions in those catheters cannot be extrapolated to BioFlo Port. The desired outcome of the 
studying flushing solutions for implanted port- catheters is to change practice, (i.e., policy and 
procedure related to care of all implanted port-catheters) if appropriate. Therefore, another 
randomized control trial using the same methodology among patients with the BioFlo Port is 
needed.  
 
The purpose of this study is to determine the rate of occlusion in BioFlo implanted port-catheters 
flushed with 20 mL of normal saline only vs those flushed with the standard practice of 20 mL of 
normal saline followed by 5 mL of heparinized saline (100 units per mL). The researchers also 
hope to conclude that the complication rate in patients whose ports are flushed with saline only is 
no greater than those of patients whose ports are flushed with the combination of saline and 
heparinized saline. These complications might include partial or complete obstruction, infection 
of the central line, and/or the onset of heparin induced thrombocytopenia. 
 
Research Question(s): 
1. Does a saline only flush maintain the patency of BioFlo Port at a rate comparable to a 
heparinized saline solution? 
 
2. Is there any difference in the type and rate of complications among BioFlo Ports flushed 
with saline only versus heparinized saline?  
 
Null Hypothesis: 
We are proposing a non-inferiority trial. Thus, the null hypothesis is: BioFlo Ports flushed with 
saline only will experience an occlusion rate of more than 10% over the occlusion rate 
experienced in implanted port catheters flushed with a heparinized saline solution.  
 
The alternative hypothesis is: BioFlo Ports flushed with saline only will experience an occlusion 
rate less than 10% over the occlusion rate experienced in implanted port catheters flushed with 
heparinized saline solution.  
 
 
 
Background Information/Literature Review: 
 
Currently at TriHealth, Inc. all implanted port catheters are flushed according to the TriHealth 
Nursing Policy and Procedure Intravenous Site Guidelines (See Appendix A). An implanted port 
catheter is flushed with 20 mL of normal saline after IV medication, blood, or blood draws. 
Heparinized saline in the amount of 5 mL (concentration 100 units/mL) is used as a final flush 


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Protocol.docx 
when no IV fluids are running and before de-accessing. This is intended to maintain patency of 
the catheter until the next use.  
 
Frequency of flushing depends on the use of the implanted port catheter (ie. frequency of visits 
in the out-patient/in-patient units for blood draws or intravenous treatments).  At TriHealth, 
implanted port catheters that are not in use are flushed a minimum of every three months with 
the same solutions and volumes as noted above (i.e., 20 mL normal saline plus 5 mL heparin 
(100 units/mL)). The policy also recommends turbulent flushing (see Appendix A). The 
turbulent flushing technique is accomplished by a push-pause rhythm every one mL for the entire 
flush volume. Turbulent flushing helps remove built-up residue, medication, and fibrin from the 
walls of the catheter. Additionally, TriHealth has adopted the use of a neutral 
displacement needle-free connector with a clear housing (the MicroCLAVE® Clear, ICU 
Medical, Inc., San Clemente, CA, USA) that features a split septum with a straight internal fluid 
path design and minimal dead space to help minimize blood reflux into the tip of the catheter 
upon connection and disconnection of the luerloc, thus reducing the risk of occlusions due to 
blood reflux.  This connector meets recommendations of the Infusion Nursing Society, Center 
for Disease Control, Federal Drug Administration and Society for Healthcare Epidemiology in 
America regarding the prevention of intravascular catheter-related bloodstream infections and 
enables clinicians to view the fluid pathway to verify effective flushing and clamp the IV line 
without requiring a specific clamping sequence. 
 
Heparin induced thrombocytopenia (HIT), an immune reaction to heparin, remains a serious 
consequence of heparin use in some patients. Patients experiencing HIT can develop deep 
venous thrombosis, pulmonary emboli, stroke, or myocardial infarction. Patients developing HIT 
thrombotic syndrome may require limb amputation and are at an increased risk for death.  The 
actual incidence of HIT is 1-5% of patients exposed to heparin (Cooney, 2006). Many clinicians 
think that HIT is under-recognized and under diagnosed. The first response to the diagnosis of 
HIT is the discontinuation of all forms of heparin, including heparin flushes. The use of heparin 
should be avoided or minimized whenever possible. If saline only flushes were found to be as 
effective as heparinized saline flushes all types of implanted port-catheters, it would significantly 
decrease the patient’s exposure to heparin, and therefore the potential to develop HIT. However, 
the evidence for recommending saline only vs saline plus heparin flushing of implanted port-
catheters remains inconsistent (Camp-Sorrell, 2010; Kannan, 2008, Lee & Johnson, 2005).   
 
The reasons for placing a BioFlo Port in a patient and the indications for use of the catheter 
(Navilyst Medical, Inc.,  2014) are the same as for placing any type of implanted port-catheter in 
a patient and maintaining the patency of the port remains a primary concern.  The BioFlo Port, 
when used with a power injectable needle, can also be used for the power injection of contrast 
media. As noted above, the manufacturer of the BioFlo Port claims that the Endexo Technology 
provides a catheter material more resistant to thrombus accumulation. However, as also noted by 
the manufacturer, the reduction in thrombus accumulation is based on platelet count in the 
catheter and supported by acute in-vitro testing only.  
 
The BioFlo Port also contains PASV Valve Technology that is “designed to resist backflow, thus 
maintaining long-term patency and provide a saline-only flushing option” (Navilyst Medical, 
Inc., 2014, pg. 2). Unfortunately, an evidence-based citation for the last statement is not 


 Maintaining Patency in BioFlo Ports …..4 
Protocol.docx 
provided. The BioFlo Port with PASV Valve Technology also claims to provide fewer 
complications when compared with nonvalved ports, namely a 47% (p=0.02) reduction in 
inadequate blood draw, a 51% (p<0.03) reduction in nursing time for troubleshooting port 
problems, and a 35% (p=0.20) reduction in tPA usage (Carlo, Lamont, McCarty, Livingston, & 
Kuhn, 2004). In the study by Carlo et al., the valved ports were flushed with 10 mL of normal 
saline while the nonvalved ports were flushed with 10 mL of heparinized saline (number of units 
of heparin per mL of saline not specified). These results are promising but it only included 73 
patients (37 in valved port group and 36 in the non-valved port group) who were followed for 
180 days. Additionally, it is only one study; subsequent studies replicating this methodology 
have not been located.  The purpose of the MicroCLAVE® Clear connector which is used with 
all implanted port catheters at TriHealth is to also help minimize blood reflux into the tip of the 
catheter upon connection and disconnection of the luerloc, thus reducing the risk of occlusions 
due to blood reflux. Therefore, in this study and the one already in progress, the type of flushing 
solution is the main focus as the materials and mechanics of the implanted port in each study are 
the same.    
 
In conclusion, Level 1 evidence for the use heparin flushes versus saline flushes for the 
maintenance of implanted port catheters is lacking in the current literature. No study has been 
conducted exclusively among patients with implanted port catheters of the same type. For 
nursing to establish an evidence-based practice guideline for flushing of implanted port catheters, 
more research is needed to generate the knowledge necessary to make recommendations that will 
change and standardize practice. 
 
Research Plan 
 
 
 
Study Design:  Non-inferiority trial in which participants will be randomly assigned to 
one of two groups: the control group or the intervention group.  
 
 
Setting for the Study: The TCI Infusion Centers, specifically: the TCI Good Samaritan 
(GS) Infusion Center at GSH; the TCI GS Infusion Center Butler County;  the Ambulatory  
Treatment Center at Bethesda North Hospital;   the TCI GS Infusion Center, Cheviot; TCI 
Infusion Center, Kenwood; TCI Infusion Center, Arrow Springs; and the TCI GS Infusion 
Center, Anderson. 
 
 
 
Participants: Patients receiving care in the identified settings who have an implanted 
port catheter will be recruited to participate in this study. 
 
 
 
Inclusion Criteria:  
• over the age of 18 years 
• 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  


 Maintaining Patency in BioFlo Ports …..5 
Protocol.docx 
• 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 
• receives routine care of the implanted port catheter at any of the 
identified TriHealth Cancer Institute Infusion Centers  
 
 
 
Exclusion Criteria:  
• has documented Heparin platelet  antibody (could not be randomized 
to either group) or other allergy to Heparin 
• receiving therapeutic dose of an anticoagulant, i.e., warfarin, heparin, 
enoxaparin, etc.  
• Does not meet one or more of the inclusion criteria 
 
Recruitment 
Prospective study participants will be identified the day prior to their appointment 
in the treatment center by a member of the research team. Their chart will be 
reviewed for inclusion criteria and flagged as a potential study participant. 
 
When the potential study participant arrives in the treatment center, a member of 
the research team will escort the patient into a treatment room and explain the 
study by reading a prepared script (see Appendix B).  If the patient expresses 
interest, the Informed Consent Statement and HIPAA Authorization form will be 
reviewed and signed.  After obtaining informed consent, a participant will be 
randomly assigned to the heparinized saline flush (control group) or saline only 
flush study group (intervention group). A color coded sticker will be placed on the 
patient’s treatment folder indicating participation in the study and group 
assignment. The random assignment process will be achieved using sequentially-
numbered opaque sealed envelopes (SNOSE) containing the group assignment. 
An yellow colored data collection face sheet (see Appendix C) will indicate 
control group; a blue colored data collection face sheet will indicate the 
intervention group.  
 
During FY 2012, 391 patients with implanted port catheters were treated in the 
OPCC. Seventy of these patients experienced an occlusion of their port that 
required the administration of alteplase (CathFlo) (Kelly Dornheggen, personal 
communication, October 12, 2012). Thus, 70 of 391 experienced an occlusion 
resulting in an occlusion rate of 18%. Some of these 70 patients experienced an 
occlusion more than once during that time. Additionally, during that time, a few 
patients had their implanted port catheters removed due to infection or 
malfunction. The exact number of patients who experienced multiple occlusions 
or had their implanted ports removed/replaced during FY2012 is unknown.  
 
During the planning of the current study evaluating implanted port catheters, we 
engaged the consultation of a biostatistician through the Center for Clinical and 
Translational Science and Training (CCTST) to conduct a power analysis to 


 Maintaining Patency in BioFlo Ports …..6 
Protocol.docx 
establish the number of participants needed in each group to determine the non-
inferiority of the alternative therapy (saline only flush). Consultation was 
provided by Mekibib Altaye, PhD, Associate Professor Cincinnati Children’s 
Hospital Medical Center, University of Cincinnati. 
 
Based on the literature and our own experience we estimated an approximate 
occlusion rate of 20% with the standard treatment (saline + heparinized saline 
flush as described above). The power analysis conducted by Dr. Altaye 
determined that, using a two group normal approximation test of proportions with 
a one-sided .05 significance level, a sample size of 198 participants per group will 
have 80% power to reject the null hypothesis that the proposed method is not 
inferior (i.e. the difference in proportions between the proposed method and the 
standard method is greater than 0.10).  Thus, we will continue to recruit 
participants in that study until 198 have been enrolled in each group for a total of 
396 study participants.    
 
Dr. Altaye was consulted again when the introduction of the BioFlo Port at 
TriHealth was discovered. It is Dr. Altaye’s recommendation that this second 
randomized controlled trial using the same methodology and power analysis 
calculations be conducted.  Thus, we will recruit 198 participants per group for a 
total of 396 participants in this study.  
 
 
Data Collection:  
Independent Variables:  Method for flushing implanted port catheters: 
• 20 mL of saline followed by 5 mL of Heparinized saline in a 
concentration of 100 units/mL    
 
 
 
 
 
 OR 
• 20 mL of saline only 
 
 
 
 
Dependent Variables:  
 
 
 
Primary Outcomes 
• Occurrence of first complete (can neither withdraw blood nor flush the 
catheter) occlusion   
• Occurrence of first partial (able to flush but unable to withdraw blood) 
occlusion 
• Frequency with which alteplase (CathFlo) has to be utilized to resolve 
an occlusion 
 
 
Secondary Outcomes 
• Number of subsequent occurrences of complete or partial occlusions 
after the first occurrence.   
• Amount of time in days that a port remains patent (flushes easily and 
able to obtain a blood return).  
▪ Amount of time between entrance in study and first incidence 
of partial or complete occlusion 


 Maintaining Patency in BioFlo Ports …..7 
Protocol.docx 
▪ Amount of time between incidences of partial or complete 
occlusion. 
• Occurrence of other complications: 
▪ Central Line-Associated Blood Stream Infection (CLABSI) – a 
laboratory-confirmed (recognized pathogen cultured from one 
or more blood cultures; organism cultured from blood is not 
related to an infection at another site) blood stream infection 
that is considered central line associated (CDC, 2012).  
▪ Develops complication related to Heparin 
• HIT (Heparin induced thrombocytopenia as measured 
by a positive HIT antibody test) 
• Other heparin allergy 
 
Moderating variables: other things that could also affect patency of the port 
• Number of times port flushed per month or frequency of flushing. 
• Use of prophylactic doses of anticoagulant drugs (e.g., enoxaparin, 
heparin, warfarin) 
• Development of a hypercoaguable state, as diagnosed by primary 
hematologist/oncologist 
• Mechanical difficulties related to port placement e.g. “Pinch-off 
syndrome” 
• Length of time port has been in place prior to entrance in study  
  
Extraneous variables:  
• Type of cancer 
• Age of participant 
 
 
Data collection tool 
The data collection tool (see Implanted Port Catheter Flushing Data 
Collection Form – Face Sheet: Appendix C and Record of Flushes: 
Appendix D) were developed by the principal and sub-investigators 
specifically for the purpose of this study. The tool was reviewed by the 
OPCC nurses for completeness and clarity. In addition to basic 
demographic information (age, gender), the nurse will record the patient’s 
type of cancer, and the diagnosis or history of any hypercoaguable state or 
use of anticoagulant medication as documented in the patient chart. The 
nurse will also document the type of implanted port catheter 
(single/double), the port location (right/left, subclavian vein (described in 
the operative note or chest x-ray), and the date the port was inserted so 
that length of time the port has been in place can be calculated. Data will 
be recorded on the Face Sheet when the patient is enrolled in the study and 
as pertinent information/events become known, i.e., as complications 
occur.  
 
With each visit to the identified treatment center, the nurse will document 
the date and characteristics related to the patency of the port catheter on 


 Maintaining Patency in BioFlo Ports …..8 
Protocol.docx 
the Record of Flushes data collection tool. In the event the blood 
withdrawal is sluggish or absent, the patient will receive a dose of 
alteplase (CathFlo) according to the TriHealth Nursing Policy: VAD: Care 
& Maintenance (Appendix A) and as ordered by the physician. Dosage 
and results of that intervention will also be recorded on the Record of 
Flushes data collection tool. In the event that any study participant 
(regardless of group assignment) requires alteplase (CathFlo) on three (3) 
consecutive visits to the treatment center, the patient’s participation in the 
study will be terminated and they will be excluded from further data 
collection. The patient will be returned to a standard maintenance protocol 
for flushing of the port as prescribed by the afore-mentioned TriHealth 
Nursing policy (see Appendix A) or as prescribed by attending physician.  
 
Participants in the control group will have yellow colored data collection 
Face Sheets while participants in the intervention group will have blue 
colored data collection Face Sheets. The Record of Flushes sheet will be 
white for patients in both groups. A blue or yellow sticker will be placed 
on the cover of the patient folder housed in treatment center noting the 
patient’s involvement in the study. The data collection Face Sheet and the 
current Record of Flushes sheet will be kept in the individual patient 
folder as long as they remain a participant in the study. As the Record of 
Flushes data sheet becomes full, they will be collected by study staff and 
placed in locked drawer in a TriHealth office.  
 
 
 
Experimental Aspect of the Study:  
 
Patients who agree to participate in this study will be randomized to either the 
control group or intervention group as explained above.  
 
Participants in the control group will have their implanted port catheters flushed 
according to the established TriHealth Nursing Policy:  Venous Access Devices 
(VAD): Care and Maintenance (see Appendix A). Following the use of the port 
catheter with no continuous fluids running, or before de-accessing a port catheter 
(removing the port needle), the port will be flushed with 20 ml of normal saline 
and 5 ml of heparinized saline in the concentration of 100 units of heparin per ml.  
 
Participants in the intervention group will have their ports flushed with normal 
saline only. That is, following the use of the port catheter with no continuous 
fluids running, or before de-accessing a port catheter (removing the port needle), 
the port will be flushed with 20 ml of normal saline. Turbulent flushing technique 
(the solution is injected using a push/pause technique every 1 mL) will be used in 
both groups and all accessed port catheters will have a neutral displacement 
connector. The MicroCLAVE® Clear displacement connector (ICU Medical, Inc., 
San Clemente, CA, USA) is the current product in use. Participants in both groups 
will be seen in a TriHealth Cancer Institute Infusion Center at a frequency 
consistent with their individual treatment plan and as outlined in the TriHealth 


 Maintaining Patency in BioFlo Ports …..9 
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Nursing Policy:  Venous Access Devices (VAD): Care and Maintenance (see 
Appendix A). Participants will remain in the study for 12 months or until they 
experience one of the potential risks noted below. Participants will be considered 
as having completed the study if they participate for 12 months.  
 
Potential risks for study participants in either arm of the study include partial 
occlusion (can instill flush solution but not withdraw blood) and complete 
occlusion (can neither instill flush solution nor withdraw blood). Study 
participants could require removal of the port if an occlusion cannot be resolved, 
and possibly require re-insertion of a new implanted port. In the event of any 
occlusion, alteplase (CathFlo) in the policy established dose and frequency (see 
Appendix A) will be instilled to resolve the occlusion. Study participants whose 
implanted ports are found occluded on three (3) consecutive visits to the treatment 
center will be excluded from further data collection, i.e., their participation in the 
study will be terminated. The standard flushing as prescribed by the TriHealth 
Nursing Policy (see Appendix A) or as prescribed by the attending physician will 
be used. Study participants whose occlusion cannot be resolved with alteplase and 
require removal of the port will also be terminated and excluded from further data 
collection. Patients who develop port infections necessitating port removal will be 
terminated and excluded from further data collection. Study participants who 
develop HIT (heparin induced thrombocytopenia) or other heparin allergy will be 
terminated and excluded from further data collection.  Likewise, patients who 
have thrombotic or embolic phenomenon requiring therapeutic anticoagulation 
will be terminated and excluded from further data collection.  
 
The study will be closed if there is evidence that study participants in the 
intervention arm experience implanted port occlusion at a disproportionate rate. 
The amount of alteplase (CathFlo) used in each group will be assessed each 
month for monitoring purposes.  
 
The undertaking of this research does require the participation of other personnel, 
facilities or departments other than those used in data collection. In the event the 
study participant is admitted to the hospital or requires some intervention using 
their implanted port catheter (e.g., CT scan with contrast), the study participant 
will have an information card describing his/her participation in the study and the 
group to which he/she has been randomized, so that the assigned flush solution is 
used, and integrity of the study can be maintained.  The study participant will 
receive the card with instructions at the time of his/her enrollment in the study 
(see Appendix E Wallet Study Card).  
      
Statistical Analysis: Descriptive statistics will be used to describe the 
participants. Differences between groups on the dependent variables will be 
calculated using t-test, Chi-Square or Fisher’s exact test as appropriate for the 
level of data under analysis (also see discussion regarding interim analysis).  
Regression analysis will be used to determine the effect of the moderating 
variables on the occurrence of occlusion in the implanted ports. Participants in the 


 Maintaining Patency in BioFlo Ports …..10 
Protocol.docx 
control group and intervention group will be further stratified based on frequency 
of port flushing. Differences in the rate of occlusion between stratified groups will 
also be calculated.     
 
Ethical Considerations: The purpose of this study is to determine the safest and most 
effective flushing solution(s) for maintaining patency in implanted port catheters. In so 
doing, study participants could be placed at potential risk for catheter occlusion. All 
catheter occlusion will be treated according to TriHealth policy, i.e., the instillation of 
alteplase (CathFlo) (see Appendix A). Potential study participants will be made aware of 
the risk when enrolled in the study (See Appendix B) script for recruiting patients into the 
study and the Informed Consent Statement).  
 
Informed Consent: Patients who meet inclusion criteria will be approached by a 
member of the research team who will explain the study, implications of their 
participation and review the Informed Consent Statement and HIPAA Authorization 
Forms (see the attached). One signed copy of the Informed Consent Form and HIPAA 
forms will be given to the study participant and another placed in their folder in the 
TriHealth Infusion Center to be scanned into their EPIC electronic health record (EHR). 
The original signed Informed Consent Statement and HIPAA will be stored in a locked 
drawer in a TriHealth office until the study is completed and closed with the IRB. The 
RN seeking consent and PI will document the informed consent process in the 
participant’s EHR. Additionally, the blue or yellow sticker on the patient folder in the 
treatment center and presence of data collection forms in the patient folder will indicate 
that the patient is a participant in the study.  
 
Privacy Information:  Once enrolled in the study, each participant will be assigned a 
study code and referred to by that code on all study related documentation.  A study 
enrollment log will be created to record each participant’s name and medical record 
number, which will be correlated with the study code so that information may be 
retrieved to check or verify missing data. To maintain confidentiality, the study 
enrollment log will be kept in a password protected file in the Nursing Research Folder 
on the Udrive of the secure TriHealth server. All completed data collection forms will 
stored in a locked cabinet in a TriHealth office. Upon completion of the study, the data 
collection sheets will be entered into a statistical database. After all data have been 
entered, the data collection tools and spreadsheets will be stored in a locked drawer in 
locked TriHealth office until the study is complete and closed with the IRB. The data file 
will be stored on the U drive in the “Implanted BioFlo Port Catheter” subdirectory of the 
Nursing Research folder until the study is complete and closed with the IRB. Only the PI 
and Sub-investigators and Nursing Lead Study Coordinator will have access to the 
Nursing Research Implanted BioFlo Port Catheters folder on the U drive. Following 
closure of the study with the TriHealth IRB, all study materials will be collected, boxed 
and placed in TriHealth designated storage for 10 years.  
 
Once IRB approval for the study is granted, all nurses in the treatment center  who 
deliver care to patients with implanted ports will receive training from Sue Partusch,  
MSN, RN-BC, AOCNS (original PI), Sharon Sanker, RN, OCN, Sarah Pelgen, BSN, RN, 


 Maintaining Patency in BioFlo Ports …..11 
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OCN and/or Nursing Lead Study Coordinator  regarding study procedures. The nurses 
designated on the personnel roster who will be obtaining Informed Consent will also 
receive training specific to that process.    
 
Cost/Budget:  
There is no increase in cost related to the maintenance of implanted port anticipated 
among study participants. Patient will be billed for care received based on the current 
TriHealth standards of care. 
  
 
Estimated Period of Time to Complete Study 
When will study begin? 
Once IRB approval received – approximately February, 2016 
Protocol Development 
Completed 
Complete 12-1-2015 
Admin Review Time 
2 weeks  
IRB Approval 
6 weeks for FULL Board 
Data collection 
Approximately 3 years 
Data analysis 
6 months from completion of all data collection and entry 
Presentation development 
(if applicable) 
6 months 
Manuscript Development 
(if applicable) 
6 to 9 months 
Journal submission process 
(if applicable) 
12 to 18 months 
Study closure 
Five years 
 
References 
 
Camp-Sorrell, D. (2010) State of the science of oncology vascular access devices. Seminars in 
Oncology Nursing. 26(2), pp.80-87. 
 
Carlo, J. T., Lamont, J. P., McCarty, T. M., Livingston, S., & Kuhn, J. A. (2004). A prospective 
randomized trial demonstrating valved implantable ports have fewer complications and 
lower overall cost than nonvalved implanted ports. The American Journal of Surgery, 
188(6), 722-727. 
 
Cooney, M.F. (2006). Heparin-Induced Thrombocytopenia, Critical Care Nurse. 26, pp. 30-36. 
 
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