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.

Study Overview

• Status: Completed
• Conditions: Hematologic Disease
• Intervention / Treatment: Device: Vortex port and Celsite port

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	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.	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.	immediately after insertion and up to a maximum of 6 months afterwards

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the ease of use (ease of access) between these 2 types of ports when accessing the port.	up to a maximum of 6 months after insertion

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: B. Braun Medical SA; RITA Medical Systems
• Investigators: Principal Investigator: Marguerite Stas, MD PhD, KU Leuven

Publications and helpful links

General Publications

• Stevens B, Barton SE, Brechbill M, Moenter S, Piel AL, Shankle D. A Randomized, Prospective Trial of Conventional Vascular Ports Vs.the Vortex
• Lamont JP, McCarty TM, Stephens JS, Smith BA, Carlo J, Livingston S, Kuhn JA. A randomized trial of valved vs nonvalved implantable ports for vascular access. Proc (Bayl Univ Med Cent). 2003 Oct;16(4):384-7. doi: 10.1080/08998280.2003.11927932.
• Goossens GA, Verbeeck G, Moons P, Sermeus W, De Wever I, Stas M. Functional evaluation of conventional 'Celsite' venous ports versus 'Vortex' ports with a tangential outlet: a prospective randomised pilot study. Support Care Cancer. 2008 Dec;16(12):1367-74. doi: 10.1007/s00520-008-0436-y. Epub 2008 Apr 15.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: June 7, 2007
• First Submitted That Met QC Criteria: June 7, 2007
• First Posted (Estimate): June 11, 2007

Study Record Updates

• Last Update Posted (Estimate): January 26, 2009
• Last Update Submitted That Met QC Criteria: January 23, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: oncology, medical; implantable catheter; vascular access ports; persistent withdrawal occlusion; Vortex®; Celsite®; Vacutainer®; venous cut-down
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: SM007