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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994136

Enrollment

1100

Registered

2009-10-14

Start date

2009-01-31

Completion date

2011-06-30

Last updated

2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Disease, Oncology, Medical

Keywords

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

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.

Interventions

DRUGnormal 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Withdrawal occlusion	within180 days

Secondary

Measure	Time frame
all catheter-related bacteremia	within 180 days
Incidence of functional problems other than withdrawal occlusion	within 180 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026