NCT07384598

Pharmacokinetic Profiles of Subcutaneous Enoxaparin for Thromboprophylaxis in Critically Ill Patients With Renal Failure Treated or Not With Continuous Veno-veinous Hemofiltration.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Clinique Saint Pierre Ottignies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Thromboprophylaxis
• Critical Illness
• Intensive Care (ICU)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin	Monitoring 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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-01
• Completion: 2027-12-31
• First posted: 2026-02-03
• Last updated: 2026-02-03