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OTIMACAT: Maintenance Optimization of the Fully Implanted Venous Catheter

Sponsor
Clinical Academic Center (2CA-Braga) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05411666
Collaborator
(none)
176
Enrollment
1
Location
2
Arms
65.1
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Saline solution maintenance of the CVC
  • Procedure: No maintenance of the CVC
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Maintenance Optimization of the Fully Implanted Venous Catheter
Actual Study Start Date :
Jun 30, 2020
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Adverse Events [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.

    Secondary Outcome Measures

    1. Occurence of AE related with infectious complications [Time since screening until follow-up visit (on average 20 months)]

      The occurrence of adverse events related to infectious complications in the 2 groups.

    2. Occurence of AE related with thrombotic complications [Time since screening until follow-up visit (on average 20 months)]

      The occurrence of adverse events related to thrombotic complications of both CVCTI and venous thrombosis in both groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Serviço de Hospital de Dia, Hospital de Braga Braga Portugal 4710-243

    Sponsors and Collaborators

    • Clinical Academic Center (2CA-Braga)

    Investigators

    • Principal Investigator: Ema Alves, Serviço de Hospital de Dia, Hospital de Braga, EPE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinical Academic Center (2CA-Braga)
    ClinicalTrials.gov Identifier:
    NCT05411666
    Other Study ID Numbers:
    • OTIMACAT
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Clinical Academic Center (2CA-Braga)
    Central venous catheter
    Additional relevant MeSH terms:
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Jun 9, 2022