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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Oncology, Medical; Hematologic Disease

Treatments: Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00994136

SM008

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Normal saline

Experimental group

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).

Treatment:

Drug: normal saline

Heparin lock

No Intervention group

Treatment:

Drug: normal saline