Maintenance Optimization of the Fully Implanted Venous Catheter (OTIMACAT)

Clinical Academic Center (2CA-Braga)

Status: Enrolling

Conditions: Cancer

Treatments: Procedure: Saline solution maintenance of the CVC; Procedure: No maintenance of the CVC

Study type: Interventional

Funder types: Other

Identifiers

NCT05411666

OTIMACAT

Details and patient eligibility

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Arm 1

Other group

Description:

Saline solution maintenance of the Central venous catheter (CVC)

Treatment:

Procedure: Saline solution maintenance of the CVC

Arm 2

Experimental group

Description:

No maintenance of the Central venous catheter (CVC)

Treatment:

Procedure: No maintenance of the CVC