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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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
Harry Schouten, MD
Maastricht University Medical Centre
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)