Sepsis
Conditions
Brief summary
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.
Detailed description
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
Interventions
None listed
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | 28 and 31 days |
Secondary
| Measure | Time frame |
|---|---|
| Severe bleeding events | 28 and 31 days |
| Length of hospital stay | 28 and 31 days |
Countries
France
Outcome results
None listed