CancerOTIMACATNCT05411666
Maintenance Optimization of the Fully Implanted Venous Catheter
A study testing Saline solution maintenance of the CVC and No maintenance of the CVC in people with Cancer, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Saline solution maintenance of the CVC and No maintenance of the CVC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Jun 2020to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Serviço de Hospital de Dia, Hospital de Braga
Braga, 4710-243
Rosana Magalhaes, 00351 253 027249
About this study
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.
Read more
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.
- Conditions
- Cancer
- Being tested
- Saline solution maintenance of the CVC, No maintenance of the CVC
- Keywords
- Central venous catheter
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solution maintenance of the CVCProcedure or surgery
Also called Saline solution maintenance
Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun, according to local standard procedures.
No maintenance of the CVCProcedure or surgery
Also called No maintenance
No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun. Just visual inspection to local site of CVC insertion.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Saline solution maintenance of the Central venous catheter (CVC) Receives: Procedure: Saline solution maintenance of the CVC |
| Arm 2 | Experimental | No maintenance of the Central venous catheter (CVC) Receives: Procedure: No maintenance of the CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time since screening until follow-up visit (on average 20 months)
Secondary outcomes (2)
Occurence of AE related with infectious complications
The occurrence of adverse events related to infectious complications in the 2 groups.
Measured: 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.
Measured: Time since screening until follow-up visit (on average 20 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 Jun 2020
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ema Alves, Principal investigator, Serviço de Hospital de Dia, Hospital de Braga, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411666
- Sponsor's protocol ID
- OTIMACAT
- Acronym
- OTIMACAT
- Status last verified
- Aug 2025
- First submitted
- 26 May 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Optimization of the Fully Implanted Venous Catheter
- ClinicalTrials.gov ID
- NCT05411666
- Acronym / sponsor ID
- OTIMACAT / OTIMACAT
- Conditions
- Cancer
- Keywords
- Central venous catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Clinical Academic Center (2CA-Braga)University, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Saline solution maintenance of the CVCSaline solution maintenance of the Central venous catheter (CVC) |
| Arm 2 | Experimental | Procedure: No maintenance of the CVCNo maintenance of the Central venous catheter (CVC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline solution maintenance of the CVCAlso: Saline solution maintenanceSaline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun, according to local standard procedures. | Procedure or surgery | Arm 1 |
| No maintenance of the CVCAlso: No maintenanceNo maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun. Just visual inspection to local site of CVC insertion. | Procedure or surgery | Arm 2 |
Primary outcome
Number of Adverse Events
Time frame: 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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ema Alves principal investigator
Serviço de Hospital de Dia, Hospital de Braga, EPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline solution maintenance of the CVC and No maintenance of the CVC in people with Cancer, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosana Magalhaes (+351 253 027 249, cro@ccabraga.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Time since screening until follow-up visit (on average 20 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.