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Completed

NCT Number: NCT00994136

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

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.

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Key information

Conditions

Oncology, Medical Hematologic Disease Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oncology and hematology patients
  • Life expectancy of minimum of 180 days

Exclusion criteria

  • second or femoral long-term central venous access device
  • known allergy to heparin (HIT)
  • coagulation disorders(INR >2, Blood platelets > 1,000,000/mm3)
  • therapeutic intravenous heparin administration

Treatment and study plan

normal saline

Drug

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)

Primary outcomes

  1. Withdrawal occlusion

    Time frame: within180 days

Secondary outcomes

  1. all catheter-related bacteremia

    Time frame: within 180 days

  2. Incidence of functional problems other than withdrawal occlusion

    Time frame: within 180 days

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Leuvens Kanker Instituut

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2009
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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