Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients
Primary Purpose
Hematological Malignancies, Bacteremia, Thrombosis
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
heparin
concentrated citrate
Sponsored by
About this trial
This is an interventional prevention trial for Hematological Malignancies focused on measuring hematological patients, central venous catheters, catheter related thrombosis, catheter related infections, concentrated citrate
Eligibility Criteria
Inclusion Criteria:
- patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
- written informed consent
- 18 years or older
Exclusion Criteria:
- the presence of a central venous catheter at admission
- history of central venous catheter related thrombosis or infection
- indication for anticoagulant treatment or prophylaxis
- patients with totally implanted catheters
- catheters impregnated with antimicrobial agents
Sites / Locations
- Atrium Medical Center Parkstad Heerlen
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A: heparin (Heparin LEO)
B: concentrated citrate (Citralock)
Arm Description
After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter.
locking the central venous catheter with concentrated citrate after each use
Outcomes
Primary Outcome Measures
central venous catheter-related thrombosis
Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.
central venous catheter-related infections
Secondary Outcome Measures
premature removal of the catheter
failure to aspirate blood
hypocalcemic symptoms
severe bleeding
Full Information
NCT ID
NCT01820962
First Posted
March 12, 2013
Last Updated
March 26, 2013
Sponsor
Maastricht University Medical Center
Collaborators
Dirinco B.V.
1. Study Identification
Unique Protocol Identification Number
NCT01820962
Brief Title
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients
Official Title
Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Because the inclusion rate was lower than expected.
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Dirinco B.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.
The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.
Detailed Description
Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.
At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies, Bacteremia, Thrombosis
Keywords
hematological patients, central venous catheters, catheter related thrombosis, catheter related infections, concentrated citrate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: heparin (Heparin LEO)
Arm Type
Active Comparator
Arm Description
After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter.
Arm Title
B: concentrated citrate (Citralock)
Arm Type
Experimental
Arm Description
locking the central venous catheter with concentrated citrate after each use
Intervention Type
Procedure
Intervention Name(s)
heparin
Intervention Description
when not in use CVCs are locked with heparin
Intervention Type
Procedure
Intervention Name(s)
concentrated citrate
Intervention Description
when not in use the CVC is locked with concentrated citrate
Primary Outcome Measure Information:
Title
central venous catheter-related thrombosis
Description
Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.
Time Frame
weekly from date of randomization until removal of the central venous catheter, up to one year
Title
central venous catheter-related infections
Time Frame
weekly from date of randomization untill the removal of the central venous catheter; up to one year
Secondary Outcome Measure Information:
Title
premature removal of the catheter
Time Frame
weekly from date of randomization untill removal of the central venous catheter; up to one year
Title
failure to aspirate blood
Time Frame
weekly from date of randomization untill the removal of the central venous catheter; up to one year
Title
hypocalcemic symptoms
Time Frame
weekly from dateof randomization untill the removal of the central venous catheter; up to one year
Title
severe bleeding
Time Frame
weekly from date of randomization untill the removal of the central venous catheter; up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
written informed consent
18 years or older
Exclusion Criteria:
the presence of a central venous catheter at admission
history of central venous catheter related thrombosis or infection
indication for anticoagulant treatment or prophylaxis
patients with totally implanted catheters
catheters impregnated with antimicrobial agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Schouten, MD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Medical Center Parkstad Heerlen
City
Heerlen
ZIP/Postal Code
6419PC
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6202AZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
17962211
Citation
Boersma RS, Jie KS, Verbon A, van Pampus EC, Schouten HC. Thrombotic and infectious complications of central venous catheters in patients with hematological malignancies. Ann Oncol. 2008 Mar;19(3):433-42. doi: 10.1093/annonc/mdm350. Epub 2007 Oct 24.
Results Reference
background
PubMed Identifier
17897607
Citation
Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
Results Reference
background
PubMed Identifier
16033861
Citation
Weijmer MC, van den Dorpel MA, Van de Ven PJ, ter Wee PM, van Geelen JA, Groeneveld JO, van Jaarsveld BC, Koopmans MG, le Poole CY, Schrander-Van der Meer AM, Siegert CE, Stas KJ; CITRATE Study Group. Randomized, clinical trial comparison of trisodium citrate 30% and heparin as catheter-locking solution in hemodialysis patients. J Am Soc Nephrol. 2005 Sep;16(9):2769-77. doi: 10.1681/ASN.2004100870. Epub 2005 Jul 20.
Results Reference
background
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Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients
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