Blood and Lymph Conditions

All Conditions

Hematologic Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Fibrinolytic Agents

Anticoagulants

Heparin

Calcium heparin

In the intervention group the use of heparin as locking solution in the catheter lumen (or lumina) when the catheter is not longer in use is omitted. Catheters are locked under positive pressure with normal saline in stead injecting an extra volume of heparinised saline (100IU/ml).

Ten milliliters of normal saline will be injected at the end of the intravenous therapy. Injection is performed with the start/stop method and with the positive pressure technique (clamping the catheter while injecting the last milliliters of normal saline)

normal saline

Marguerite Stas, MD, PhD

Long-term central venous access devices are considered as safe for the administration of medication as chemotherapy, but are also used for blood sampling. For years these catheters have been locked with a heparin solution in order to avoid occlusion. However, no scientific evidence supports heparin locking when the device is not in use. Advanced technology as needleless caps and valved catheters and port reservoirs confirms this trend to use 'saline only' for locking these devices. Therefore the investigators hypothesize is that there will be no difference in proportion of occlusions and catheter related bacteremia in long-term venous access devices locked with 'saline only' versus with heparin.

Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters

Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial

Leuvens Kanker Instituut

Universitaire Ziekenhuizen KU Leuven

Marguerite Stas

Vortex port and Celsite port

Marguerite Stas, MD PhD

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.

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

RITA Medical Systems

B. Braun Medical SA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters	NCT00994136	Oncology, Medic... Hematologic Dis...	normal saline	1 Year -	Universitaire Ziekenhuizen KU Leuven
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters	NCT00994136	Oncology, Medic... Hematologic Dis...	normal saline	1 Year -	Universitaire Ziekenhuizen KU Leuven
Functional Evaluation of Two Types of Totally Implanted Venous Ports	NCT00484848	Hematologic Dis...	Vortex port and...	18 Years -	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for oncology, medical