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Annals of Oncology Advance Access published online on November 29, 2005
Annals of Oncology, doi:10.1093/annonc/mdj059
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© 2005 European Society for Medical Oncology
Received August 3, 2005
Revised September 26, 2005
Accepted September 27, 2005

original article

Dalteparin for prevention of catheter-related complications in cancer patients with central venous catheters: final results of a double-blind, placebo-controlled phase III trial

M. Karthaus 1 *, A. Kretzschmar 2, H. Kröning 3, M. Biakhov 4, D. Irwin 5, N. Marschner 6, C. Slabber 7, G. Fountzilas 8, A. Garin 9, N. G. F. Abecasis 10, W. Baronius 11, G. G. Steger 12, T. Südhoff 13, C. Giorgetti 14, and P. Reichardt 2

1 Evang. Johannes-Krankenhaus, Medizinische Klinik, Bielefeld
2 Robert-Rössle-Klinik, HELIOS-Klinikum Berlin-Buch, Charité Campus Buch, Berlin
3 Krankenhaus Altstadt, Klinik für Hämatologie/Onkologie, Magdeburg, Germany
4 Central Clinical Hospital, Moscow, Russia
5 Alta Bates Comprehensive Cancer Center, Berkeley, CA, USA
6 Onkologische Schwerpunktpraxis, Freiburg, Germany
7 Mary Potter Oncology Centre, Little Company of Mary Medical Centre, Pretoria, South Africa
8 AHEPA Hospital, Aristotele University of Thessaloniki, Thessaloniki, Greece
9 Cancer Research Center Department of Clinical Pharmacology, Moscow, Russia
10 Instituto Português de Oncologia Francisco Gentil Centro Regional de Lisboa, Lisbon, Portugal
11 Klinikum Chemnitz, Germany
12 Department of Internal Medicine I, University of Vienna, Austria
13 Department of Internal Medicine, Knappschaftskrankenhaus Ruhr University Bochum; Germany
14 Pharmacia, Gruppo Pfizer Inc., Milano, Italy

* To whom correspondence should be addressed.
M. Karthaus, E-mail: Meinolf.Karthaus{at}evkb.de


  Abstract

Background: Cancer patients receiving chemotherapy experience thromboembolic complications associated with the use of long-term indwelling central venous catheters (CVCs). This prospective, double-blind, placebo-controlled, multicenter study evaluated whether prophylactic treatment with a low molecular weight heparin could prevent clinically relevant catheter-related thrombosis.

Patients and methods: Patients with cancer undergoing chemotherapy for at least 12 weeks (n = 439) were randomly assigned, in a 2:1 ratio, to receive either dalteparin (5000 IU) or placebo, by subcutaneous injection, once daily for 16 weeks. Patients underwent upper extremity evaluation with either venography or ultrasound at the time of a suspected catheter-related complication (CRC) or upon completion of study medication. The primary end point, as determined by a blinded adjudication committee, was the occurrence of a CRC, defined as the first occurrence of any one of the following: clinically relevant catheter-related thrombosis that was symptomatic or that required anticoagulant or fibrinolytic therapy; catheter-related clinically relevant pulmonary embolism; or catheter obstruction requiring catheter removal.

Results: There was no significant difference in the frequency of CRCs between the dalteparin arm (3.7%) and the placebo arm (3.4%; P = 0.88), corresponding to a relative risk of 1.0883 (95% confidence interval 0.37-3.19). No difference in the time to CRC was observed between the two arms (P = 0.83). There was no significant difference between the dalteparin and placebo groups in terms of major bleeding (1 versus 0) or overall safety.

Conclusions: Dalteparin prophylaxis did not reduce the frequency of thromboembolic complications after CVC implantation in cancer patients. Dalteparin was demonstrated to be safe over 16 weeks of treatment in these patients.

Keywords: cancer therapy; catheter-related complication; prophylaxis; venous thrombosis.
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