Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A: heparin (Heparin LEO) 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. |
Procedure: heparin
when not in use CVCs are locked with heparin
|
| Experimental: B: concentrated citrate (Citralock) locking the central venous catheter with concentrated citrate after each use |
Procedure: concentrated citrate
when not in use the CVC is locked with concentrated citrate
|
Outcome Measures
Primary Outcome Measures
- central venous catheter-related thrombosis [weekly from date of randomization until removal of the central venous catheter, up to one year]
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 [weekly from date of randomization untill the removal of the central venous catheter; up to one year]
Secondary Outcome Measures
- premature removal of the catheter [weekly from date of randomization untill removal of the central venous catheter; up to one year]
- failure to aspirate blood [weekly from date of randomization untill the removal of the central venous catheter; up to one year]
- hypocalcemic symptoms [weekly from dateof randomization untill the removal of the central venous catheter; up to one year]
- severe bleeding [weekly from date of randomization untill the removal of the central venous catheter; up to one year]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atrium Medical Center Parkstad Heerlen | Heerlen | Netherlands | 6419PC | |
| 2 | Maastricht University Medical Center | Maastricht | Netherlands | 6202AZ |
Sponsors and Collaborators
- Maastricht University Medical Center
- Dirinco B.V.
Investigators
- Principal Investigator: Harry Schouten, MD, Maastricht University Medical Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2007 Oct 24. Review.
- 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. Review.
- 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. Epub 2005 Jul 20.
- MEC06-2-003