Functional Evaluation of Two Types of Totally Implanted Venous Ports

Hematologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484848
• Other study ID #: SM007
• Status: Completed
• Phase: N/A
• First received: June 7, 2007
• Last updated: January 23, 2009
• Start date: September 2004
• Est. completion date: March 2005

Study information

• Verified date: January 2009
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Disease
• Hematologic Diseases

Intervention

Device:
• Vortex port and Celsite port

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	B. Braun Medical SA, RITA Medical Systems

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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):1367-7 — View Citation

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. — View Citation

Stevens B, Barton SE, Brechbill M, Moenter S, Piel AL, Shankle D. A Randomized, Prospective Trial of Conventional Vascular Ports Vs.the Vortex

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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