Extrait

The investigators' primary research objective is: - To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on: - the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin prophylaxis; - the risk of major bleeding during the treatment period. The investigators' secondary research objectives are: - To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients with severe renal insufficiency; - To identify clinical and laboratory factors that predict an excessive anticoagulant effect (anti-Xa > 0.10 IU/mL); - To estimate the relationship between trough anti-Xa levels and bleeding. The DIRECT Pilot Study: Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.

Critère d'inclusion

• Renal Insufficiency

Liens

• ictrp
• nct