Clinical Trials Directory

Trials / Terminated

TerminatedNCT01820962

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

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

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
212 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREheparinwhen not in use CVCs are locked with heparin
PROCEDUREconcentrated citratewhen not in use the CVC is locked with concentrated citrate

Timeline

Start date
2006-07-01
Primary completion
2010-12-01
Completion
2012-07-01
First posted
2013-03-29
Last updated
2013-03-29

Locations

2 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01820962. Inclusion in this directory is not an endorsement.