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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Rosana Magalhaes
- Telefonnummer: +351 253 027 249
- E-post: cro@ccabraga.org
Studiesteder
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Braga, Portugal, 4710-243
- Rekruttering
- Serviço de Hospital de Dia, Hospital de Braga
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Ta kontakt med:
- Rosana Magalhaes
- Telefonnummer: 00351 253 027249
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Adverse Events
Tidsramme: 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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurence of AE related with infectious complications
Tidsramme: Time since screening until follow-up visit (on average 20 months)
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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
Tidsramme: 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.
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Time since screening until follow-up visit (on average 20 months)
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ema Alves, Serviço de Hospital de Dia, Hospital de Braga, EPE
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OTIMACAT
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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