Functional Evaluation of Two Types of Totally Implanted Venous Ports

NCT00484848 | Completed

• 1 other identifier: SM007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Disease

Keywords

oncology, medical; implantable catheter; vascular access ports; persistent withdrawal occlusion; Vortex®; Celsite®; Vacutainer®; venous cut-down

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Interventions

Vortex port and Celsite port DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• request of a standard size totally implanted venous port
• patent superior vena cava
• normal clotting tests (PT\>40% and platelet count \>40000/mm3)

You may not qualify if:

• unable to provide written informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• RITA Medical Systems: collaborator
• B. Braun Medical SA: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

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

  BACKGROUND

• 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.

  PMID: 16278752 BACKGROUND

• 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.

  PMID: 18414904 RESULT

MeSH Terms

Conditions

Hematologic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Marguerite Stas, MD PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 11, 2007
• Study Start: September 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: March 1, 2005
• Last Updated: January 26, 2009

Record last verified: 2009-01

Locations

BE (1)