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Functional Evaluation of Two Types of Totally Implanted Venous Ports
This study has been completed.
Study NCT00484848   Information provided by Universitaire Ziekenhuizen Leuven
First Received: June 7, 2007   Last Updated: January 23, 2009   History of Changes

June 7, 2007
January 23, 2009
September 2004
December 2004   (final data collection date for primary outcome measure)
  • Evaluation of the difference in difficulty in blood drawing between the 2 types of ports when accessing the port under identical maintenance procedure according to the guidelines in the University Hospitals Leuven. [ Time Frame: up to a maximum of 6 months after insertion ]
  • Evaluation of the difference in one-way or bidirectional occlusion incidence between these 2 types of ports, when accessing the port under identical maintenance procedure according to the guidelines in the University Hospitals Leuven. [ Time Frame: up to a maximum of 6 months after insertion ]
  • Evaluation of the difference in filling time for blood sampling between these 2 types of ports when using a standard 10 ml vacuum blood tube and a 19 G Gripper® needle. [ Time Frame: immediately after insertion and up to a maximum of 6 months afterwards ]
Same as current
Complete list of historical versions of study NCT00484848 on ClinicalTrials.gov Archive Site
Evaluation of the ease of use (ease of access) between these 2 types of ports when accessing the port. [ Time Frame: up to a maximum of 6 months after insertion ]
Same as current
 
Functional Evaluation of Two Types of Totally Implanted Venous Ports
Functional Evaluation of Conventional Venous Access Port (Celsite®) Versus Venous Access Port With Tangential Outlet (Vortex®) : a Prospective Randomized Pilot Study

Totally implanted venous access ports allow a safe delivery of medication, mainly chemotherapy, but are also used for blood sampling. This last procedure is not always successful, as it appeared from a nurse's survey in different hospitals in Flanders, including the University Hospitals in Leuven, Belgium. In 3 to 29 percent of the attempts, blood withdrawal is impaired or not possible, as an intermittent or permanent fact. This is in line with international literature data where difficulty in blood draw was noted in 6 to 26% of port accessions. Partial or total occlusion leads to discomfort for the patient, delay in therapy, higher costs and extra nursing time.

A new port system with a tangential outlet (Vortex port) was designed and according to the manufacturer, this shape will allow to cleanse the entire reservoir of the port more efficiently and avoid the formation of precipitates of medication or blood that could lead to an obstruction of the device. These precipitates are also regarded as a potential risk factor for infection.

However, only one previously published small randomised study addressed the value of the Vortex port when compared to conventional access devices: Stevens et al. were able to show a reduction in obstruction incidence from 26% to 7% with the use of the Vortex port. The incidence of blood withdrawal problems in our experience with conventional ports in University hospitals Leuven was 8% thus lower than that reported by Stevens, but this remains the most frequent problem faced by care providers and patients.

With this study, the investigators aim to compare the performance of the tangential outlet ports and that of a "conventional" port in order to assess an eventual functional difference.

 
 
Interventional
Supportive Care, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study
Hematologic Disease
Device: Vortex port and Celsite port
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
200
March 2005
December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • request of a standard size totally implanted venous port
  • patent superior vena cava
  • normal clotting tests (PT>40% and platelet count >40000/mm3)

Exclusion Criteria:

  • unable to provide written informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00484848
 
SM007
Universitaire Ziekenhuizen Leuven
  • RITA Medical Systems
  • B. Braun Medical SA
Principal Investigator: Marguerite Stas, MD PhD Katholieke Universiteit Leuven
Universitaire Ziekenhuizen Leuven
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP