Evaluation of the optimal dose of prophylactic anticoagulation with low- molecular- weight heparin administered subcutaneously to critically ill patients – part 2 - LMWH prophylaxis for ICU patients

• Conditions: venous thromboembolism; MedDRA version: 12.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis

• Registration Number: EUCTR2010-022034-88-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-24
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.