Functional Evaluation of Two Types of Totally Implanted Venous Ports

This study has been completed.
Sponsor:
Collaborators:
RITA Medical Systems
B. Braun Medical SA
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00484848
First received: June 7, 2007
Last updated: January 23, 2009
Last verified: January 2009
  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, 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.


Condition Intervention
Hematologic Disease
Device: Vortex port and Celsite port

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Functional Evaluation of Conventional Venous Access Port (Celsite®) Versus Venous Access Port With Tangential Outlet (Vortex®) : a Prospective Randomized Pilot Study

Resource links provided by NLM:


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
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00484848     History of Changes
Other Study ID Numbers: SM007
Study First Received: June 7, 2007
Last Updated: January 23, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Hematologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014