Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05411666

Maintenance Optimization of the Fully Implanted Venous Catheter

Led by Clinical Academic Center (2CA-Braga) · Updated on 2025-08-15

176

Participants Needed

1

Research Sites

313 weeks

Total Duration

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AI-Summary

What this Trial Is About

Central venous catheter (CVC) are intravascular devices used in clinical practice, namely to administer fluid therapy, parenteral nutrition, drugs, blood products, hemodynamic monitoring, also being a gateway to the collection of blood samples or laboratory monitoring. The fully implanted central venous catheter (CVCTI) is a type of central venous access surgically placed, which is characterized by containing a subcutaneous reservoir that is accessed by puncturing the camera with a blunt needle, widely used in cancer patients. The fully implanted central venous catheter is recommended when there is a need for intermittent vascular access and of long duration. The maintenance of the CVCTI, as it's the necessity, frequency, and method is subject of some controversy, with discrepancies between the various cancer centers and guidance documents, once they occur several different intervals and maintenance methods. The objective of this study is to assess the necessity of frequent maintenance of fully implanted central venous catheter, still assuring its viability and holding the same or lower number incidence of complications. Participants in this study are cancer patients with a CVC fully implanted for chemotherapy, in follow-up phase. Participants will be randomized in one of two arms: Maintenance with saline solution and no maintenance.

CONDITIONS

Official Title

Maintenance Optimization of the Fully Implanted Venous Catheter

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Cancer patients with a fully implanted central venous catheter placed for chemotherapy follow-up
  • Chemotherapy completed within the past 10 weeks
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Signed informed consent indicating understanding and agreement to participate
Not Eligible

You will not qualify if you...

  • Presence of metastases or any condition requiring intravenous treatments or additional chemotherapy
  • History of adverse events related to the central venous catheter during treatment
  • Current use of anticoagulant medication
  • History of thrombophilia
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Serviço de Hospital de Dia, Hospital de Braga

Braga, Portugal, 4710-243

Actively Recruiting

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Research Team

R

Rosana Magalhaes

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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