Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hematological Malignancies, Bacteremia, Thrombosis

Intervention / Treatment
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* Procedure: heparin
* Procedure: concentrated citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: heparin (Heparin LEO)<br>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<br>* when not in use CVCs are locked with heparin<br>|
| Experimental: B: concentrated citrate (Citralock)<br>locking the central venous catheter with concentrated citrate after each use | Procedure: concentrated citrate<br>* when not in use the CVC is locked with concentrated citrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | weekly from date of randomization until removal of the central venous catheter, up to one year | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematological patients, central venous catheters, catheter related thrombosis, catheter related infections, concentrated citrate