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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820962
• Other study ID #: MEC06-2-003
• Status: Terminated
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: March 26, 2013
• Start date: July 2006
• Est. completion date: July 2012

Study information

• Verified date: March 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 212
• Est. completion date: July 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bacteremia
• Catheter-Related Infections
• Hematological Malignancies
• Thrombosis

Intervention

Procedure:
• heparin
when not in use CVCs are locked with heparin
• concentrated citrate
when not in use the CVC is locked with concentrated citrate

Locations

Country	Name	City	State
Netherlands	Atrium Medical Center Parkstad Heerlen	Heerlen
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dirinco B.V.

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. Epub 2007 Oct 24. Review. — View 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. Review. — View 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. Epub 2005 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	central venous catheter-related infections		weekly from date of randomization untill the removal of the central venous catheter; up to one year	No
Secondary	premature removal of the catheter		weekly from date of randomization untill removal of the central venous catheter; up to one year	No
Secondary	failure to aspirate blood		weekly from date of randomization untill the removal of the central venous catheter; up to one year	No
Secondary	hypocalcemic symptoms		weekly from dateof randomization untill the removal of the central venous catheter; up to one year	No
Secondary	severe bleeding		weekly from date of randomization untill the removal of the central venous catheter; up to one year	Yes