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

This study has been completed.
Sponsor:
Collaborator:
Leuvens Kanker Instituut
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00994136
First received: October 13, 2009
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Oncology, Medical
Hematologic Disease
Drug: normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Withdrawal occlusion [ Time Frame: within180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all catheter-related bacteremia [ Time Frame: within 180 days ] [ Designated as safety issue: No ]
  • Incidence of functional problems other than withdrawal occlusion [ Time Frame: within 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal saline
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).
Drug: normal saline
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)
No Intervention: Heparin lock Drug: normal saline
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)

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00994136

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Leuvens Kanker Instituut
Investigators
Principal Investigator: Marguerite Stas, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

Publications:

Responsible Party: Marguerite Stas, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00994136     History of Changes
Other Study ID Numbers: SM008
Study First Received: October 13, 2009
Last Updated: June 8, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
Catheters, indwelling
Catheterization, Central Venous
Withdrawal occlusion
Heparin lock

Additional relevant MeSH terms:
Hematologic Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014