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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Rosana Magalhaes
- Telefonnummer: +351 253 027 249
- E-post: cro@ccabraga.org
Studieorter
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-
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Braga, Portugal, 4710-243
- Rekrytering
- Serviço de Hospital de Dia, Hospital de Braga
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Kontakt:
- Rosana Magalhaes
- Telefonnummer: 00351 253 027249
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: Arm 1
Saline solution maintenance of the Central venous catheter (CVC)
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Saline solution maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun, according to local standard procedures.
Andra namn:
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Experimentell: Arm 2
No maintenance of the Central venous catheter (CVC)
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No maintenance of the Central venous catheter (CVC) - Celsite IMPLANTOFIX from B|Braun.
Just visual inspection to local site of CVC insertion.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Adverse Events
Tidsram: Time since screening until follow-up visit (on average 20 months)
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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.
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Time since screening until follow-up visit (on average 20 months)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurence of AE related with infectious complications
Tidsram: Time since screening until follow-up visit (on average 20 months)
|
The occurrence of adverse events related to infectious complications in the 2 groups.
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Time since screening until follow-up visit (on average 20 months)
|
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Occurence of AE related with thrombotic complications
Tidsram: Time since screening until follow-up visit (on average 20 months)
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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)
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Ema Alves, Serviço de Hospital de Dia, Hospital de Braga, EPE
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OTIMACAT
Läkemedels- och apparatinformation, studiedokument
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