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Functional Evaluation of Two Types of Totally Implanted Venous Ports

This study has been completed.

Sponsors and Collaborators: Universitaire Ziekenhuizen Leuven
RITA Medical Systems
B. Braun Medical SA
Information provided by: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00484848
  Purpose

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, we aim to compare the performance of the tangential outlet ports and that of a “conventional” port in order to assess an eventual functional difference.


Condition Intervention
Oncology, Medical
Hematologic Disease
Device: Vortex port and Celsite port

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Functional Evaluation of Conventional Venous Access Port (Celsite®) Versus Venous Access Port With Tangential Outlet (Vortex®) : a Prospective Randomized Pilot Study

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment:   200
Study Start Date:   September 2004
Study Completion Date:   March 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484848

Locations
Belgium
University Hospitals Leuven    
      Leuven, Belgium, 3000

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
RITA Medical Systems
B. Braun Medical SA

Investigators
Principal Investigator:     Marguerite Stas, MD PhD     Katholieke Universiteit Leuven    
  More Information

Publications:

Study ID Numbers:   SM007
First Received:   June 7, 2007
Last Updated:   June 7, 2007
ClinicalTrials.gov Identifier:   NCT00484848
Health Authority:   Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
implantable catheter  
vascular access ports  
persistent withdrawal occlusion  
Vortex®  
Celsite®
Vacutainer®
venous cut-down

Study placed in the following topic categories:
Hematologic Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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