N/A
N=436
Maintaining Patency in Implanted Port Catheters
Obstruction; Catheter, Infusion Catheter (Vascular) · Catheter; Complications (Indwelling Catheter)
Bottom Line
View on ClinicalTrials.gov: NCT02354118 ↗Enrolled (actual)
436
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants With First Complete Occlusion Within 1 Year — 5; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heparinized saline catheter flush (Other); Saline-only catheter flush (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TriHealth Inc.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Complete Occlusion Within 1 Year |
5; 4 | — |
| PRIMARY Number of Participants With First Partial Occlusion Within 1 Year |
39; 55 | — |
| PRIMARY Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year |
39; 55 | — |
| SECONDARY Number of Participants With First Complete or Partial Occlusion Within 1 Year |
43; 59 | — |
| SECONDARY Number of Participants With HIT Within 1 Year |
0; 0 | 1.0 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02354118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.