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

NCT ID: NCT01820962

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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

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Hematological Malignancies Bacteremia Thrombosis

Keywords

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hematological patients central venous catheters catheter related thrombosis catheter related infections concentrated citrate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A: heparin (Heparin LEO)

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.

Group Type ACTIVE_COMPARATOR

heparin

Intervention Type PROCEDURE

when not in use CVCs are locked with heparin

B: concentrated citrate (Citralock)

locking the central venous catheter with concentrated citrate after each use

Group Type EXPERIMENTAL

concentrated citrate

Intervention Type PROCEDURE

when not in use the CVC is locked with concentrated citrate

Interventions

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heparin

when not in use CVCs are locked with heparin

Intervention Type PROCEDURE

concentrated citrate

when not in use the CVC is locked with concentrated citrate

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dirinco B.V.

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harry Schouten, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

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Atrium Medical Center Parkstad Heerlen

Heerlen, , Netherlands

Site Status

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 17962211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17897607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16033861 (View on PubMed)

Other Identifiers

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MEC06-2-003

Identifier Type: -

Identifier Source: org_study_id