The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.

The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:

• To describe the characteristics of the patients treated with Xigris®

  • socio-demographic characteristics,
  • clinical profile

• To determine the conditions of use of Xigris®

  • To describe previous treatments,
  • To observe delay before Xigris® initiation,
  • To describe dose, duration of treatment,
  • To study the concomitant treatments and the associated treatments

• To describe the clinical evolution of the patients

  • To observe mortality after 1 month
  • To describe reasons of death

Patients are eligible to be included in the study if they meet the following criteria

• Patients treated with Xigris® during the study period in intensive care units in France
• Patients with a minimum age of 18 years
• Patients who are presenting in the normal course of care

All adult patients treated with Xigris® between January 1st, 2006 and August 31st 2008 in intensive care units in France will be enrolled retrospectively, whereas all adult patients treated with Xigris® between September 1st, 2008 and September 1st, 2009 will be enrolled prospectively.