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

Hematologic Disease Clinical Trial

Official title:

Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994136
• Other study ID #: SM008
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: June 8, 2011
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Disease
• Hematologic Diseases
• Oncology, Medical

Intervention

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)

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Leuvens Kanker Instituut

Country where clinical trial is conducted

Belgium, 

References & Publications (18)

Bazelly B, Lotz JP, Milleron B. [The maintenance of totally implantable perfusion sites]. Rev Pneumol Clin. 1994;50(1):43-4. French. — View Citation

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. — View Citation

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

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. — View Citation

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.

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. — View Citation

Hadaway LC. Flushing to reduce central catheter occlusions. Nursing. 2000 Oct;30(10):74. — View Citation

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. Erratum in: Am J Infect Control. 2008 Nov;36(9):655. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Theard JL, Robard S. [Outcome of usage protocols on implantable devices]. Ann Fr Anesth Reanim. 1995;14(6):534-5. French. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal occlusion		within180 days	No
Secondary	all catheter-related bacteremia		within 180 days	No
Secondary	Incidence of functional problems other than withdrawal occlusion		within 180 days	No