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

Primary Purpose

Oncology, Medical, Hematologic Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
normal saline
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oncology, Medical focused on measuring Catheters, indwelling, Catheterization, Central Venous, Withdrawal occlusion, Heparin lock

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitaire Ziekenhuizen Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Normal saline

Heparin lock

Arm 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).

Outcomes

Primary Outcome Measures

Withdrawal occlusion

Secondary Outcome Measures

all catheter-related bacteremia
Incidence of functional problems other than withdrawal occlusion

Full Information

First Posted
October 13, 2009
Last Updated
June 8, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Leuvens Kanker Instituut
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1. Study Identification

Unique Protocol Identification Number
NCT00994136
Brief Title
Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters
Official Title
Locking of Totally Implanted Venous Access Devices and Tunneled Catheters With or Without Heparin: a Randomised Open-labeled Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Leuvens Kanker Instituut

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Medical, Hematologic Disease
Keywords
Catheters, indwelling, Catheterization, Central Venous, Withdrawal occlusion, Heparin lock

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Experimental
Arm 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).
Arm Title
Heparin lock
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
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)
Primary Outcome Measure Information:
Title
Withdrawal occlusion
Time Frame
within180 days
Secondary Outcome Measure Information:
Title
all catheter-related bacteremia
Time Frame
within 180 days
Title
Incidence of functional problems other than withdrawal occlusion
Time Frame
within 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marguerite Stas, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
10174683
Citation
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PubMed Identifier
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Safety of Catheter Lock With or Without Heparin in Implanted Central Venous Catheters

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