Maintenance Optimization of the Fully Implanted Venous Catheter
NCT ID: NCT05411666
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2020-06-30
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1
Saline solution maintenance of the Central venous catheter (CVC)
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.
Arm 2
No maintenance of the Central venous catheter (CVC)
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of CVCTI-related adverse events during the treatment phase
* Patients on anticoagulant medication
* History of thrombophilia
* Pregnancy/Breastfeeding
18 Years
ALL
No
Sponsors
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Clinical Academic Center (2CA-Braga)
OTHER
Responsible Party
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Principal Investigators
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Ema Alves
Role: PRINCIPAL_INVESTIGATOR
Serviço de Hospital de Dia, Hospital de Braga, EPE
Locations
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Serviço de Hospital de Dia, Hospital de Braga
Braga, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Rosana Magalhaes
Role: primary
Other Identifiers
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OTIMACAT
Identifier Type: -
Identifier Source: org_study_id
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