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PREMO Study: to Investigate Port REMoval Outcomes (PREMO)

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ClinicalTrials.gov Identifier: NCT03948958
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by (Responsible Party):
Stas Marguerite, Universitaire Ziekenhuizen Leuven

Brief Summary:
A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.

Condition or disease Intervention/treatment Phase
Neoplasms Cystic Fibrosis Other: Evaluation of the catheter function Other: Catheter tip location, thrombus, sleeve and device damage visualization Other: Catheter-related colonization Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD Other: Macroscopic evaluation of the port chamber and catheter Not Applicable

Detailed Description:

A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure.

Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year.

This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TIVAD evaluation
TIVAD evaluation at port removal evaluation of catheter function, visualization of catheter tip, presence of thrombus material and sleeve and any device damage during linogram (contrast injection via TIVAD), tip and chamber content microbiological culture, macroscopic catheter and port chamber evaluation PROM: patient reported outcome measurements regarding TIVAD insertion, presence and removal
Other: Evaluation of the catheter function
Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)

Other: Catheter tip location, thrombus, sleeve and device damage visualization
Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram

Other: Catheter-related colonization
TIVAD colonization will be investigated by microbiological culture of the tip and chamber content

Other: patient-reported outcome measures (PROM) related to the presence of the TIVAD
PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.

Other: Macroscopic evaluation of the port chamber and catheter
Macroscopic evaluation of the port chamber and catheter will be performed after port removal.




Primary Outcome Measures :
  1. TIVAD function [ Time Frame: during the 1 day of TIVAD removal, before the linogram ]
    will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification.


Secondary Outcome Measures :
  1. Catheter tip position visualization by fluoroscopy [ Time Frame: during the 1 day of TIVAD removal, just before the linogram ]
    The patient will be positioned in a nearly standing position with chest elevation of 17°

  2. Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory [ Time Frame: during the 1 day of TIVAD removal ]
    will be visualised by linogram (digital substraction angiography)

  3. Catheter tip and port chamber culture [ Time Frame: during the 1 day of TIVAD removal (following TIVAD removal) ]
    microbial culture


Other Outcome Measures:
  1. Patient-reported outcome measure [ Time Frame: during the 1 day of TIVAD removal ]
    Patient's experiences will be collected by means of the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire a self-reported 25-items questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment.
  • Patients planned for an elective TIVAD removal under local anaesthesia.
  • Patients able to participate in the study and willing to sign an informed consent.
  • Patients able to understand and read Dutch.

Exclusion Criteria:

• History of fever and/or chills following last flushing procedure


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948958


Contacts
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Contact: Marguerite Stas, MD, PhD +3216346839 ext 46839 marguerite.stas@uzleuven.be
Contact: Martine Jérôme, MSc, RN +3216346764 ext 46764 martine.jerome@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Martine Jérôme, MSc RN    +3216346764    martine.jerome@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
B. Braun Medical SA
Investigators
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Principal Investigator: Marguerite Stas, MD, PhD Universitaire Ziekenhuizen Leuven
Publications:

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Responsible Party: Stas Marguerite, Professor Doctor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03948958    
Other Study ID Numbers: S62321
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stas Marguerite, Universitaire Ziekenhuizen Leuven:
Vascular Access Devices
Implantable port
Flush interval
Catheter function
Catheter-related infection
Catheter tip location
Catheter tip thrombus
Catheter sleeve
Patient-reported outcome measure
Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases