Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters - Full Text View

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:

MedlinePlus related topics: Blood Disorders Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

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

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:

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.

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. Review.

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. French. No abstract available.

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.

Theard JL, Robard S. [Outcome of usage protocols on implantable devices] Ann Fr Anesth Reanim. 1995;14(6):534-5. French. No abstract available.

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.

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(R)' venous ports versus 'Vortex(R)' ports with a tangential outlet: a prospective randomised pilot study. Support Care Cancer. 2008 Dec;16(12):1367-74. 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.

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. No abstract available. Erratum in: Am J Infect Control. 2008 Nov;36(9):655.

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. 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.

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.

Hadaway LC. Flushing to reduce central catheter occlusions. Nursing. 2000 Oct;30(10):74. No abstract available.

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
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013