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

U

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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