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

NCT01820962 | Terminated Phase 3

• 1 other identifier: MEC06-2-003
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematological Malignancies; Bacteremia; Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• central venous catheter-related infections

  weekly from date of randomization untill the removal of the central venous catheter; up to one year

Secondary Outcomes (4)

• premature removal of the catheter

  weekly from date of randomization untill removal of the central venous catheter; up to one year

• failure to aspirate blood

  weekly from date of randomization untill the removal of the central venous catheter; up to one year

• hypocalcemic symptoms

  weekly from dateof randomization untill the removal of the central venous catheter; up to one year

• severe bleeding

  weekly from date of randomization untill the removal of the central venous catheter; up to one year

Study Arms (2)

A: heparin (Heparin LEO)

ACTIVE COMPARATOR

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.

Procedure: heparin

B: concentrated citrate (Citralock)

EXPERIMENTAL

locking the central venous catheter with concentrated citrate after each use

Procedure: concentrated citrate

Interventions

heparin PROCEDURE

when not in use CVCs are locked with heparin

A: heparin (Heparin LEO)

concentrated citrate PROCEDURE

when not in use the CVC is locked with concentrated citrate

B: concentrated citrate (Citralock)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
• written informed consent
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Dirinco B.V.: collaborator

Study Sites (2)

Atrium Medical Center Parkstad Heerlen

Heerlen, 6419PC, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6202AZ, Netherlands

Location

Related 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. doi: 10.1093/annonc/mdm350. Epub 2007 Oct 24.

  PMID: 17962211 BACKGROUND

• 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.

  PMID: 17897607 BACKGROUND

• 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.

  PMID: 16033861 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Bacteremia; Thrombosis; Catheter-Related Infections

Interventions

Heparin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Harry Schouten, MD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 29, 2013
• Study Start: July 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2012
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

NL (2)