Acute Illness
Conditions
Keywords
Medical prevention therapy
Brief summary
The primary objective: * To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization. The secondary objective: * To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization. * To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .
Interventions
DRUGEnoxaparin
40 mg once daily for 6 to 14 days (10 ± 4 days)
DRUGPlacebo
Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
List of inclusion and
Exclusion criteria
Inclusion Criteria: * Hospitalization within 48 hours prior randomization for at least one of the following medical acute medical illness: * Acute decompensation of heart failure * Severe systemic infection and at least one of the following: * Chronic pulmonary diseases (COPD, pulmonary fibrosis, pulmonary restrictive syndrome…) * Obesity (BMI ≥ 30kg/m2) * Personal history of VTE * Age ≥ 60 years * Active cancer (defined as being histologically confirmed with an initial diagnosis or recurrence or metastasis within the past 6 months) excluding planned hospitalization for chemotherapy * Anticipated duration of hospitalization at least 6 days * Health status: * ASA Health status score ≤ 3 (American Society of Anesthesiologists) * ECOG ≤ 2 in cancer patient * Anticipated life expectancy \> 1 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death rate with all causes mortality | At day 30 |
| Hemorrhages | Occuring until day 90 |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | Between randomization and day 90 |
| Adverse events, serious adverse events | During the entire observation period (from informed consent signature until Day 90) |
Countries
Brazil, China, Hong Kong, India, Malaysia, Mexico, Philippines, South Korea, Tunisia
Outcome results
None listed