Obstruction; Catheter, Infusion Catheter (Vascular)Phase 4NCT02923830
Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
A Phase 4 study testing Heparinized saline catheter flush and Saline-only catheter flush in people with Obstruction; Catheter, Infusion Catheter (Vascular) and Catheter; Complications (Indwelling Catheter), run by TriHealth Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstruction; Catheter, Infusion Catheter (Vascular), Catheter; Complications (Indwelling Catheter)
- What is being tested?
- Heparinized saline catheter flush and Saline-only catheter flush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2016to 26 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
TriHealth Cancer Institute Good Samaritan Infusion Center at GSH
Cincinnati, Ohio, 45220
Ambulatory Treatment Center at Bethesda North TriHealth Hospital
Cincinnati, Ohio, 45242
TriHealth Cancer Institute Good Samaritan Infusion Center, Medicenter
Cincinnati, Ohio, 45242
TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot
Cincinnati, Ohio, 45247
TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson
Cincinnati, Ohio, 45255
TriHealth Cancer Institute Good Samaritan Infusion Center Butler County
Hamilton, Ohio, 45011
About this study
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.
Read the 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.
- Conditions
- Obstruction; Catheter, Infusion Catheter (Vascular), Catheter; Complications (Indwelling Catheter)
- Being tested
- Heparinized saline catheter flush, Saline-only catheter flush
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparinized saline catheter flushOther
Also called Control group
The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
Saline-only catheter flushDrug
Also called Intervention group
The intervention group will have their port catheters flushed with saline only.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Heparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months Receives: Other: Heparinized saline catheter flush |
| Intervention Group | Experimental | Saline-only catheter flush - The intervention group will have their port catheters flushed with saline only. Receives: Drug: Saline-only catheter flush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline to 1 year
Secondary outcomes (4)
Number of Complete or Partial Occlusions
The number of complete or partial occlusions after the first occurrence will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017
- Study completion26 Mar 2019
Why it stopped: We stopped inserting BioFlo ports, no more patients to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstruction; Catheter, Infusion Catheter (Vascular)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Baker, TriHealth Inc.
- Investigators
- Sharon Sanker, RN, OCN, Principal investigator, TriHealth Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923830
- Sponsor's protocol ID
- 15-117
- Status last verified
- May 2019
- First submitted
- 30 Sep 2016
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Study terminated
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
- ClinicalTrials.gov ID
- NCT02923830
- Acronym / sponsor ID
- 15-117
- Conditions
- Obstruction; Catheter, Infusion Catheter (Vascular), Catheter; Complications (Indwelling Catheter)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We stopped inserting BioFlo ports, no more patients to recruit
- Enrolment
- 28 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Heparinized saline catheter flushHeparinized saline catheter flush - The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months |
| Intervention Group | Experimental | Drug: Saline-only catheter flushSaline-only catheter flush - The intervention group will have their port catheters flushed with saline only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparinized saline catheter flushAlso: Control groupThe control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months | Other | Control Group |
| Saline-only catheter flushAlso: Intervention groupThe intervention group will have their port catheters flushed with saline only. | Drug | Intervention Group |
Primary outcome
Number of Participants With Occurrence of First Complete Occlusion (Blockage)
Time frame: baseline to 1 year
Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded.
Number of Participants With Occurrence of First Partial Occlusion (Blockage)
Time frame: baseline to 1 year
Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded.
Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion
Time frame: baseline to 1 year
Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded.
4 secondary outcomes
Number of Complete or Partial Occlusions
Time frame: baseline to 1 year
Number of Days Catheter Remains Patent (Unobstructed)
Time frame: baseline to 1 year
Central Line-Associated Blood Stream Infection (CLABSI)
Time frame: baseline to 1 year
Heparin-related Complication
Time frame: baseline to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Study terminated
Related trials for Obstruction; Catheter, Infusion Catheter (Vascular)
RecruitingPhase 4
Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters
Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Sanker, RN, OCN principal investigator
TriHealth Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparinized saline catheter flush and Saline-only catheter flush in people with Obstruction; Catheter, Infusion Catheter (Vascular) and Catheter; Complications (Indwelling Catheter), run by TriHealth Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Occurrence of First Complete Occlusion (Blockage) (time frame: baseline to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.