Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters
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ClinicalTrials.gov Identifier: NCT00994136 |
Recruitment Status
:
Completed
First Posted
: October 14, 2009
Last Update Posted
: June 9, 2011
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Condition or disease | Intervention/treatment | Phase |
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Oncology, Medical Hematologic Disease | Drug: normal saline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
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).
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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)
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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)
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- Withdrawal occlusion [ Time Frame: within180 days ]
- all catheter-related bacteremia [ Time Frame: within 180 days ]
- Incidence of functional problems other than withdrawal occlusion [ Time Frame: within 180 days ]

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Ages Eligible for Study: | 1 Year and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994136
Belgium | |
Universitaire Ziekenhuizen Leuven | |
Leuven, Vlaams-Brabant, Belgium, 3000 |
Principal Investigator: | Marguerite Stas, MD, PhD | Universitaire Ziekenhuizen Leuven |
Publications:
Responsible Party: | Marguerite Stas, Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT00994136 History of Changes |
Other Study ID Numbers: |
SM008 |
First Posted: | October 14, 2009 Key Record Dates |
Last Update Posted: | June 9, 2011 |
Last Verified: | June 2011 |
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 |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |