Maintenance Optimization of the Fully Implanted Venous Catheter

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Number of Adverse Events [Срок оценки: Time since screening until follow-up visit (on average 20 months)]

Вторичные конечные точки (2)

• Occurence of AE related with infectious complications [Срок оценки: Time since screening until follow-up visit (on average 20 months)]
• Occurence of AE related with thrombotic complications [Срок оценки: Time since screening until follow-up visit (on average 20 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Португалия · 1 центр

• Serviço de Hospital de Dia, Hospital de Braga — Braga

Идентификаторы

NCT: NCT05411666 · OTIMACAT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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