Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters
NCT ID: NCT00994136
Last Updated: 2011-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1100 participants
INTERVENTIONAL
2009-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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).
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)
Heparin lock
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)
Interventions
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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 Criteria
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Inclusion Criteria
* Life expectancy of minimum of 180 days
Exclusion Criteria
* known allergy to heparin (HIT)
* coagulation disorders(INR \>2, Blood platelets \> 1,000,000/mm3)
* therapeutic intravenous heparin administration
1 Year
ALL
No
Sponsors
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Leuvens Kanker Instituut
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Universitaire Ziekenhuizen Leuven
Principal Investigators
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Marguerite Stas, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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References
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Stephens LC, Haire WD, Tarantolo S, Reed E, Schmit-Pokorny K, Kessinger A, Klein R. Normal saline versus heparin flush for maintaining central venous catheter patency during apheresis collection of peripheral blood stem cells (PBSC). Transfus Sci. 1997 Jun;18(2):187-93. doi: 10.1016/s0955-3886(97)00008-8.
Kadidal VV, Mayo DJ, Horne MK. Heparin-induced thrombocytopenia (HIT) due to heparin flushes: a report of three cases. J Intern Med. 1999 Sep;246(3):325-9. doi: 10.1046/j.1365-2796.1999.00527.x.
Rama BN, Haake RE, Bander SJ, Ghasem-Zadeh A, Gorla C. Heparin-flush associated thrombocytopenia--induced hemorrhage: a case report. Nebr Med J. 1991 Dec;76(12):392-4.
Bazelly B, Lotz JP, Milleron B. [The maintenance of totally implantable perfusion sites]. Rev Pneumol Clin. 1994;50(1):43-4. No abstract available. French.
Randolph AG, Cook DJ, Gonzales CA, Andrew M. Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials. BMJ. 1998 Mar 28;316(7136):969-75. doi: 10.1136/bmj.316.7136.969.
Theard JL, Robard S. [Outcome of usage protocols on implantable devices]. Ann Fr Anesth Reanim. 1995;14(6):534-5. doi: 10.1016/s0750-7658(05)80501-5. No abstract available. French.
Smith S, Dawson S, Hennessey R, Andrew M. Maintenance of the patency of indwelling central venous catheters: is heparin necessary? Am J Pediatr Hematol Oncol. 1991 Summer;13(2):141-3. doi: 10.1097/00043426-199122000-00005.
Brown-Smith JK, Stoner MH, Barley ZA. Tunneled catheter thrombosis: factors related to incidence. Oncol Nurs Forum. 1990 Jul-Aug;17(4):543-9.
Kelly C, Dumenko L, McGregor SE, McHutchion ME. A change in flushing protocols of central venous catheters. Oncol Nurs Forum. 1992 May;19(4):599-605.
Goossens GA, Verbeeck G, Moons P, Sermeus W, De Wever I, Stas M. Functional evaluation of conventional 'Celsite' venous ports versus 'Vortex' ports with a tangential outlet: a prospective randomised pilot study. Support Care Cancer. 2008 Dec;16(12):1367-74. doi: 10.1007/s00520-008-0436-y. Epub 2008 Apr 15.
McDiarmid S, Hamelin L, Huebsch LB. Leading change: Retrospective evaluation of a nurse-led initiative in vascular access options for autologous stem cell transplant recipients ranging from Hickman catheters to peripherally inserted central catheters. J Infus Nurs. 2006 Mar-Apr;29(2):81-8. doi: 10.1097/00129804-200603000-00005.
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
Caers J, Fontaine C, Vinh-Hung V, De Mey J, Ponnet G, Oost C, Lamote J, De Greve J, Van Camp B, Lacor P. Catheter tip position as a risk factor for thrombosis associated with the use of subcutaneous infusion ports. Support Care Cancer. 2005 May;13(5):325-31. doi: 10.1007/s00520-004-0723-1. Epub 2004 Nov 5.
Petersen J, Delaney JH, Brakstad MT, Rowbotham RK, Bagley CM Jr. Silicone venous access devices positioned with their tips high in the superior vena cava are more likely to malfunction. Am J Surg. 1999 Jul;178(1):38-41. doi: 10.1016/s0002-9610(99)00124-5.
Brouns F, Schuermans A, Verhaegen J, De Wever I, Stas M. Infection assessment of totally implanted long-term venous access devices. J Vasc Access. 2006 Jan-Mar;7(1):24-8. doi: 10.1177/112972980600700105.
Hadaway LC. Flushing to reduce central catheter occlusions. Nursing. 2000 Oct;30(10):74. doi: 10.1097/00152193-200030100-00037. No abstract available.
Ryder M. The role of biofilm in vascular catheter-related infections. 15-25. 2001. Ref Type: Serial (Book,Monograph)
Cossey V, Thelissen MJ, Goossens GA, Stas M, Schuermans A. Needleless positive-pressure mechanical valve connectors: are they safe? Clin Microbiol Infect 2008;S121-666.doi:10.1111/j.1469-0691.2008.02007.x.
Other Identifiers
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SM008
Identifier Type: -
Identifier Source: org_study_id
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