Clinical trial NCT05411666: Maintenance Optimization of the Fully Implanted Venous Catheter
Official title: Maintenance Optimization of the Fully Implanted Venous Catheter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Central venous catheter
Lead sponsor: Clinical Academic Center (2CA-Braga)
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Time since screening until follow-up visit (on average 20 months)
Secondary outcomes:
measure: Occurence of AE related with infectious complications
timeFrame: Time since screening until follow-up visit (on average 20 months)
measure: Occurence of AE related with thrombotic complications
timeFrame: Time since screening until follow-up visit (on average 20 months)
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Serviço de Hospital de Dia, Hospital de Braga
Study officials:
affiliation: Serviço de Hospital de Dia, Hospital de Braga, EPE
name: Ema Alves
role: PRINCIPAL_INVESTIGATOR
References: