Functional Evaluation of Two Types of Totally Implanted Venous Ports

Condition(s) targeted: Oncology, Medical; Hematologic Disease

Intervention: Vortex port and Celsite port (Device)

Phase: N/A

Status: Completed

Sponsored by: Universitaire Ziekenhuizen Leuven

Official(s) and/or principal investigator(s):
Marguerite Stas, MD PhD, Principal Investigator, Affiliation: Katholieke Universiteit Leuven

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.

Official title: Functional Evaluation of Conventional Venous Access Port (Celsite®) Versus Venous Access Port With Tangential Outlet (Vortex®) : a Prospective Randomized Pilot Study

Study design: Supportive Care, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

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.

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.

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.

Secondary outcome: Evaluation of the ease of use (ease of access) between these 2 types of ports when accessing the port.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University Hospitals Leuven, Leuven 3000, Belgium

Related publications:

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.

Starting date: September 2004
Ending date: March 2005
Last updated: June 7, 2007