Maintenance Optimization of the Fully Implanted Venous Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saline solution maintenance of the CVC, No maintenance of the CVC.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Saline solution maintenance of the CVC
Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun, according to local standard procedures. - Procedure No maintenance of the CVC
No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B\|Braun. Just visual inspection to local site of CVC insertion.
Primary outcome measures
- Number of Adverse Events [Time frame: Time since screening until follow-up visit (on average 20 months)]
Secondary outcome measures (2)
- Occurence of AE related with infectious complications [Time frame: Time since screening until follow-up visit (on average 20 months)]
- Occurence of AE related with thrombotic complications [Time frame: Time since screening until follow-up visit (on average 20 months)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Portugal · 1 center
- Serviço de Hospital de Dia, Hospital de Braga — Braga
Identifiers
NCT: NCT05411666 · OTIMACAT