Maintenance Optimization of the Fully Implanted Venous Catheter

Cancer Clinical Trial

— OTIMACAT  

Official title:

Maintenance Optimization of the Fully Implanted Venous Catheter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411666
• Other study ID #: OTIMACAT
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2022
• Source: Clinical Academic Center (2CA-Braga)
• Contact: Rosana Magalhaes
• Phone: +351 253 027 249
• Email: cro[@]ccabraga.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Serviço de Hospital de Dia, Hospital de Braga	Braga

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Academic Center (2CA-Braga)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)