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Completed

NCT Number: NCT03948958

PREMO Study: to Investigate Port REMoval Outcomes

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.

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Key information

Conditions

Neoplasms Catheter-Related Infections Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the catheter function

Other

Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)

Catheter tip location, thrombus, sleeve and device damage visualization

Other

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

Catheter-related colonization

Other

TIVAD colonization will be investigated by microbiological culture of the tip and chamber content

patient-reported outcome measures (PROM) related to the presence of the TIVAD

Other

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.

Macroscopic evaluation of the port chamber and catheter

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • B. Braun Medical SA

Registry information

Official study title

Pilot Trial to Assess Functional, Microbial, Radiological and Patient Reported Outcomes at Totally Implantable Venous Access Device (Port) Removal (PREMO Study)

Acronym: PREMO

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 14, 2019
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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