Maintenance Optimization of the Fully Implanted Venous Catheter
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinical Academic Center (2CA-Braga)
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Saline solution maintenance of the CVC
Procedure/SurgerySaline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun, according to local standard procedures.
No maintenance of the CVC
Procedure/SurgeryNo maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun. Just visual inspection to local site of CVC insertion.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Arm 1Other 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Trial outcomes
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 frame
Time since screening until follow-up visit (on average 20 months)Secondary outcomes
1
Occurence of AE related with infectious complications
The occurrence of adverse events related to infectious complications in the 2 groups.
Time frame
Time since screening until follow-up visit (on average 20 months)2
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 frame
Time since screening until follow-up visit (on average 20 months)Sponsors and contacts
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Source ClinicalTrials.gov