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

Maastricht University Medical Centre (MUMC)

Status and phase: Terminated; Phase 3

Conditions: Hematological Malignancies; Bacteremia; Thrombosis

Treatments: Procedure: heparin; Procedure: concentrated citrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01820962

MEC06-2-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

A: heparin (Heparin LEO)

Active Comparator group

Description:

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.

Treatment:

Procedure: heparin

B: concentrated citrate (Citralock)

Experimental group

Description:

locking the central venous catheter with concentrated citrate after each use

Treatment:

Procedure: concentrated citrate