Bacteremia, Hematological Malignancies, Thrombosis
Conditions
Keywords
hematological patients, central venous catheters, catheter related thrombosis, catheter related infections, concentrated citrate
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.
Interventions
PROCEDUREheparin
when not in use CVCs are locked with heparin
PROCEDUREconcentrated citrate
when not in use the CVC is locked with concentrated citrate
Sponsors
Dirinco B.V.
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed