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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Hematological Malignancies, Bacteremia, Thrombosis

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Trial Information

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
hemodialysis patients.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

central venous catheter-related thrombosis

Outcome Description:

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.

Outcome Time Frame:

weekly from date of randomization until removal of the central venous catheter, up to one year

Safety Issue:

No

Principal Investigator

Harry Schouten, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Centre

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MEC06-2-003

NCT ID:

NCT01820962

Start Date:

July 2006

Completion Date:

July 2012

Related Keywords:

  • Hematological Malignancies
  • Bacteremia
  • Thrombosis
  • hematological patients
  • central venous catheters
  • catheter related thrombosis
  • catheter related infections
  • concentrated citrate
  • Bacteremia
  • Neoplasms
  • Thrombosis
  • Hematologic Neoplasms
  • Catheter-Related Infections

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