Clinical trial NCT01820962: Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hematological Malignancies
Bacteremia
Thrombosis
Keywords: hematological patients
central venous catheters
catheter related thrombosis
catheter related infections
concentrated citrate
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dirinco B.V.
First posted: 2013-03-29
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: central venous catheter-related thrombosis
timeFrame: weekly from date of randomization until removal of the central venous catheter, up to one year
measure: central venous catheter-related infections
timeFrame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
Secondary outcomes:
measure: premature removal of the catheter
timeFrame: weekly from date of randomization untill removal of the central venous catheter; up to one year
measure: failure to aspirate blood
timeFrame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
measure: hypocalcemic symptoms
timeFrame: weekly from dateof randomization untill the removal of the central venous catheter; up to one year
measure: severe bleeding
timeFrame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medical Center Parkstad Heerlen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Centre
name: Harry Schouten, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boersma RS, Jie KS, Verbon A, van Pampus EC, Schouten HC. Thrombotic and infectious complications of central venous catheters in patients with hematological malignancies. Ann Oncol. 2008 Mar;19(3):433-42. doi: 10.1093/annonc/mdm350. Epub 2007 Oct 24.
citation: Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
citation: Weijmer MC, van den Dorpel MA, Van de Ven PJ, ter Wee PM, van Geelen JA, Groeneveld JO, van Jaarsveld BC, Koopmans MG, le Poole CY, Schrander-Van der Meer AM, Siegert CE, Stas KJ; CITRATE Study Group. Randomized, clinical trial comparison of trisodium citrate 30% and heparin as catheter-locking solution in hemodialysis patients. J Am Soc Nephrol. 2005 Sep;16(9):2769-77. doi: 10.1681/ASN.2004100870. Epub 2005 Jul 20.