Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
Summary
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.