About this trial
Thromboprophylaxis is recommended for critically ill patients without contraindications and is usually achieved by the subcutaneous daily administration of a low dose of low molecular weight heparin (LMWH). The efficacy of this measure can be assessed by measuring the anticoagulation level obtained in the blood by dosing the anti-Xa activity. However, multiple studies have shown that anti-Xa activities in critically ill patients in the intensive care unit (ICU) are much lower, and below the desired range, than their ward counterparts.
LMWH elimination depends on kidney function and reduced dosing is recommended for patients with renal failure, treated or not with renal replacement therapy (continuous veno-venous hemofiltration (CVVH)). However, some scarce data suggest that even critically ill patients with renal failure treated with reduced or even with standard doses of LMWH, also have lower anti-Xa activities (below the desired range). If confirmed, this finding may suggest that reduced or even standard dosing of LMWH for thromboprophylaxis in critically ill patients with renal failure should be replaced by another dosing regimen or another route of administration. Therefore, this study aims to better characterize the pharmacokinetic profiles of LMWH after administration of a prophylactic dose of enoxaparin daily in patients with renal failure treated or not with CVVH, and to compare them to patients with no renal failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 year old
Hospitalized in the ICU.
Equiped with an arterial line.
Indication for thromboprophylaxis with a daily prophylactic dose of enoxaparin.
Disqualifiers
Platelet count < 50 000/μl.
CHILD PUGH stage C cirrhosis.
Known coagulation disorder.
Patient treated in the last 3 days with direct oral anticoagulants.
Trial design
Single group
Treatments tested in this trial
Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin
Diagnostic testMonitoring of the antifactor Xa activity will be performed immediately before (H0), 4(H4), 8(H8), 12 (H12), and 24 (H24) hours after up to 3 doses of LMWH administration.
Treatment groups
Trial outcomes
Primary outcomes
mean peak anti-Xa activity
The primary endpoint will be the difference in the mean peak anti-Xa activity 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin in critically ill patients with renal failure without CVVH (N=20), in patients with renal failure with CVVH (N=20) and in a control group of patients with no renal failure (N=20).
Secondary outcomes
Mean area under the curve (AUC) (0-24 hours) of anti-Xa activity
Trough value of anti-Xa activity
Locations
Sponsors and contacts
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