Maintenance Optimization of the Fully Implanted Venous Catheter

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Procedure: No maintenance of the CVC; Procedure: Saline solution maintenance of the CVC

• Registration Number: NCT05411666
• Lead Sponsor: Clinical Academic Center (2CA-Braga)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-30
• Status Verified: 2022-05
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-06
• Last Update Submitted: 2022-06-06
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	No maintenance of the CVC	No maintenance of the Central venous catheter (CVC)
Arm 1	Saline solution maintenance of the CVC	Saline solution maintenance of the Central venous catheter (CVC)

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	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 Outcome Measures

Name	Time	Method
Occurence of AE related with infectious complications	Time since screening until follow-up visit (on average 20 months)	The occurrence of adverse events related to infectious complications in the 2 groups.
Occurence of AE related with thrombotic complications	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.

Trial Locations

Locations (1)

Serviço de Hospital de Dia, Hospital de Braga; 🇵🇹 Braga, Portugal