title: Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study.
abstract: OBJECTIVE
  Whether an anticoagulant prophylaxis is needed for patients with cancer with a central venous catheter is a highly controversial subject. We designed a study to compare different prophylactic strategies over 3 months of treatment.
  
  
  METHODS
  We performed a phase III prospective, open-label randomized trial. After the insertion of a central venous access device, consecutive patients with planned chemotherapy for cancer were randomized to no anticoagulant prophylaxis, low molecular weight heparin [low molecular weight heparin (LMWH); with isocoagulation doses], or warfarin 1 mg/day. Treatments were given over the first 3 months. Doppler ultrasound and venographies were performed on days 1 and 90, respectively, or sooner in case of clinical presumption of thrombosis.
  
  
  RESULTS
  A total of 420 patients were randomized, and 407 were evaluable. Forty-two catheter-related deep vein thrombosis (DVT) occurred (10.3 %), 20 in those with no anticoagulation, 8 in those receiving warfarin, and 14 in those receiving LMWH. Nine additional non-related catheter deep vein thrombosis (CDVT) occurred. Anticoagulation significantly reduced the incidence of catheter-related DVT (p = 0.035) and catheter non-related DVT (p = 0.007), with no difference between warfarin and LMWH. Safety was good (3.4 % of attributable events) but compliance with randomized prophylaxis was lower than expected.
  
  
  CONCLUSIONS
  Prophylaxis showed a benefit regarding catheter-related and non-catheter-related DVT with no increase in serious side effects.
authors: Department of Medical Oncology, University Hospital, Limoges, France. sandrine.lavau-denes@chu-limoges.fr
authors: Sandrine
authors: S
authors: Lavau-Denes
authors: P
authors: P
authors: Lacroix
authors: A
authors: A
authors: Maubon
authors: P M
authors: PM
authors: Preux
authors: D
authors: D
authors: Genet
authors: L
authors: L
authors: Vénat-Bouvet
authors: J L
authors: JL
authors: Labourey
authors: J
authors: J
authors: Martin
authors: P
authors: P
authors: Slaouti
authors: N
authors: N
authors: Tubiana-Mathieu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D062905:Central Venous Catheters / Q000009:adverse effects*; D005260:Female; D005602:France / Q000453:epidemiology; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D057194:Intention to Treat Analysis; D059012:Lost to Follow-Up; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D056824:Upper Extremity Deep Vein Thrombosis / Q000453:epidemiology / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000150:complications / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D000970:Antineoplastic Agents; D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin