Maintenance Optimization of the Fully Implanted Venous Catheter

NCT05411666 | Recruiting

• 1 other identifier: OTIMACAT
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

Central venous catheter

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  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.

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

Secondary Outcomes (2)

• Occurence of AE related with infectious complications

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

• Occurence of AE related with thrombotic complications

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

Study Arms (2)

Arm 1

OTHER

Saline solution maintenance of the Central venous catheter (CVC)

Procedure: Saline solution maintenance of the CVC

Arm 2

EXPERIMENTAL

No maintenance of the Central venous catheter (CVC)

Procedure: No maintenance of the CVC

Interventions

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.

Also known as: Saline solution maintenance

Arm 1

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.

Also known as: No maintenance

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Academic Center (2CA-Braga): lead

Study Sites (1)

Serviço de Hospital de Dia, Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ema Alves

  Serviço de Hospital de Dia, Hospital de Braga, EPE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosana Magalhaes

CONTACT

+351 253 027 249; cro@ccabraga.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 9, 2022
• Study Start: June 30, 2020
• Primary Completion: June 1, 2026
• Study Completion: July 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

PT (1)