Maintenance Optimization of the Fully Implanted Venous Catheter (OTIMACAT)

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 Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Procedure: Saline solution maintenance of the CVC; Procedure: No maintenance of the CVC

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosana Magalhaes; Phone Number: +351 253 027 249; Email: cro@ccabraga.org

Study Locations

• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Serviço de Hospital de Dia, Hospital de Braga
    • Contact: Rosana Magalhaes; Phone Number: 00351 253 027249

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 1; Saline solution maintenance of the Central venous catheter (CVC)	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.; Other Names: Saline solution maintenance
Experimental: Arm 2; No maintenance of the Central venous catheter (CVC)	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.; Other Names: No maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Clinical Academic Center (2CA-Braga)
• Investigators: Principal Investigator: Ema Alves, Serviço de Hospital de Dia, Hospital de Braga, EPE

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Central venous catheter
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: OTIMACAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No