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NCT Number: NCT05411666

Maintenance Optimization of the Fully Implanted Venous Catheter

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Serviço de Hospital de Dia, Hospital de Braga

Braga, 4710-243, Portugal

Location status: Recruiting

Location contact

Rosana Magalhaes

CONTACT

00351 253 027249

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years of age.
  • Cancer patients, undergoing placement of CVCTI for chemotherapy, in follow-up, who finished chemotherapy up to a maximum period of 10 weeks.
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Evidence of signed and dated informed consent indicating that the patient has been informed of all relevant aspects of the study and agrees to participate.

Exclusion criteria

  • Presence of metastases or any other condition that may be an indication for intravenous treatments or additional chemotherapy regimens
  • History of CVCTI-related adverse events during the treatment phase
  • Patients on anticoagulant medication
  • History of thrombophilia
  • Pregnancy/Breastfeeding

Treatment and study plan

Saline solution maintenance of the CVC

Procedure

Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun, according to local standard procedures.

Other names: Saline solution maintenance

No maintenance of the CVC

Procedure

No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun. Just visual inspection to local site of CVC insertion.

Other names: No maintenance

Primary outcomes

  1. Number of Adverse Events

    Time frame: Time since screening until follow-up visit (on average 20 months)

    The occurrence of any adverse event related to the use of the CVCTI, thus allowing to assess the difference between the 2 groups with as much data as possible.

Secondary outcomes

  1. Occurence of AE related with infectious complications

    Time frame: Time since screening until follow-up visit (on average 20 months)

    The occurrence of adverse events related to infectious complications in the 2 groups.

  2. Occurence of AE related with thrombotic complications

    Time frame: Time since screening until follow-up visit (on average 20 months)

    The occurrence of adverse events related to thrombotic complications of both CVCTI and venous thrombosis in both groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosana Magalhaes

CONTACT

[email protected]

+351 253 027 249

Sponsors and collaborators

Lead sponsor

Clinical Academic Center (2CA-Braga)

Other

Registry information

Acronym: OTIMACAT

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2022
Registry last updated
Aug 15, 2025

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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