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

Study Overview
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Brief Summary
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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.

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

Conditions
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Oncology, Medical, Hematologic Disease

Intervention / Treatment
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* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal saline<br>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). | Drug: normal saline<br>* 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)<br>|
| No Intervention: Heparin lock<br> | Drug: normal saline<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal occlusion |  | within180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all catheter-related bacteremia |  | within 180 days | 
| Incidence of functional problems other than withdrawal occlusion |  | within 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheters, indwelling, Catheterization, Central Venous, Withdrawal occlusion, Heparin lock