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

October 13, 2009
June 8, 2011
January 2009
June 2011   (final data collection date for primary outcome measure)
Withdrawal occlusion [ Time Frame: within180 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00994136 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Oncology, Medical
  • Hematologic Disease
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)
  • 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).
    Intervention: Drug: normal saline
  • No Intervention: Heparin lock
    Intervention: Drug: normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00994136
SM008
No
Marguerite Stas, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Leuvens Kanker Instituut
Principal Investigator: Marguerite Stas, MD, PhD Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP