Maintenance Optimization of the Fully Implanted Venous Catheter

Study Overview
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Brief Summary
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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.

Official Title
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Maintenance Optimization of the Fully Implanted Venous Catheter

Conditions
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Cancer

Intervention / Treatment
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* Procedure: Saline solution maintenance of the CVC
* Procedure: No maintenance of the CVC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Saline solution maintenance of the Central venous catheter (CVC) | Procedure: Saline solution maintenance of the CVC<br>* Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun, according to local standard procedures.<br>* Other names: Saline solution maintenance;|
| Experimental: Arm 2<br>No maintenance of the Central venous catheter (CVC) | Procedure: No maintenance of the CVC<br>* No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun. Just visual inspection to local site of CVC insertion.<br>* Other names: No maintenance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of AE related with infectious complications | The occurrence of adverse events related to infectious complications in the 2 groups. | Time since screening until follow-up visit (on average 20 months) | 
| Occurence of AE related with thrombotic complications | The occurrence of adverse events related to thrombotic complications of both CVCTI and venous thrombosis in both groups. | Time since screening until follow-up visit (on average 20 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central venous catheter