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

NCT00994136 | Completed Phase 4

• 1 other identifier: SM008
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oncology, Medical; Hematologic Disease

Keywords

Catheters, indwelling; Catheterization, Central Venous; Withdrawal occlusion; Heparin lock

Outcome Measures

Primary Outcomes (1)

• Withdrawal occlusion

  within180 days

Secondary Outcomes (2)

• all catheter-related bacteremia

  within 180 days

• Incidence of functional problems other than withdrawal occlusion

  within 180 days

Study Arms (2)

Normal saline

EXPERIMENTAL

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

Heparin lock

NO INTERVENTION

Drug: normal saline

Interventions

normal saline DRUG

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Oncology and hematology patients
• Life expectancy of minimum of 180 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Leuvens Kanker Instituut: collaborator

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (18)

• 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.

  PMID: 10174683 BACKGROUND

• 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.

  PMID: 10476001 BACKGROUND

• 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.

  PMID: 1784321 BACKGROUND

• 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.

  PMID: 7973333 BACKGROUND

• 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.

  PMID: 9550955 BACKGROUND

• 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.

  PMID: 8745984 BACKGROUND

• 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.

  PMID: 2069221 BACKGROUND

• Brown-Smith JK, Stoner MH, Barley ZA. Tunneled catheter thrombosis: factors related to incidence. Oncol Nurs Forum. 1990 Jul-Aug;17(4):543-9.

  PMID: 2399167 BACKGROUND

• 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.

  PMID: 1603675 BACKGROUND

• 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.

  PMID: 18414904 BACKGROUND

• 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.

  PMID: 16569997 BACKGROUND

• 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.

  PMID: 18538699 BACKGROUND

• 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.

  PMID: 15538639 BACKGROUND

• 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.

  PMID: 10456700 BACKGROUND

• 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.

  PMID: 16596525 BACKGROUND

• Hadaway LC. Flushing to reduce central catheter occlusions. Nursing. 2000 Oct;30(10):74. doi: 10.1097/00152193-200030100-00037. No abstract available.

  PMID: 11096978 BACKGROUND

• Ryder M. The role of biofilm in vascular catheter-related infections. 15-25. 2001. Ref Type: Serial (Book,Monograph)

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marguerite Stas, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

BE (1)