venous thromboembolism MedDRA version: 12.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Interventions
Trade Name: Klexane®
Pharmaceutical Form: Injection*
INN or Proposed INN: ENOXAPARIN SODIUM
CAS Number: 01/08/9041
Current Sponsor code: 6624
Concentration unit: mg/ml milligram(s)/millilitre
Concen
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted to the intensive care unit with stays in the ICU> 24 hours, age> 18 years, weight between 50 and 90 kg will be included in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with planned or emergency surgery within the study period, pregnant women, patients with heparin-induced thrombocytopenia or uncontrolled bleeding and patients with acute renal failure requiring CVVHDF therapy will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to measure the effect of different doses of enoxaparin (Klexane ®) (40mg x1, 30mg x2, 40mg x2 and 1mg/kg) administered subcutaneously in ICU patients by determining anti-Xa activity before (0 hours) and after 4, 12, 16 and 24 hours. This will assess the dose to be given to achieve antithrombotic activity (anti-Xa level 0.1 to 0.3 µ / ml). Anti-Xa activity is the primary endpoint.;Secondary Objective: The concentrations of AT3, fibrinogen, D-dimer and platelet count will also be determined at time 0, 12 and 24 hours. They are secondary parameters . ;Primary end point(s): Anti-Xa activity is the primary endpoint. | — |
Countries
Denmark
Outcome results
None listed