Clinical trial · Interventional
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters
Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Disease | — | UNRESOLVED | — |
| Oncology, Medical | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Normal saline
- description
- 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).
- interventionNames
- Drug: normal saline
- type
- NO_INTERVENTION
- label
- Heparin lock
- interventionNames
- Drug: normal saline
Primary outcomes (1)
- measure
- Withdrawal occlusion
- timeFrame
- within180 days
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDStephens 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
- BACKGROUNDKadidal 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
- BACKGROUNDRama 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
- BACKGROUNDBazelly 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
- BACKGROUNDRandolph 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
- BACKGROUNDTheard 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
- BACKGROUNDSmith 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
- BACKGROUNDBrown-Smith JK, Stoner MH, Barley ZA. Tunneled catheter thrombosis: factors related to incidence. Oncol Nurs Forum. 1990 Jul-Aug;17(4):543-9.