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

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.

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Key information

Conditions

Thromboprophylaxis Critical Illness Disease Attributes Intensive Care (ICU) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 year old
Hospitalized in the ICU.
Equiped with an arterial line.
Indication for thromboprophylaxis with a daily prophylactic dose of enoxaparin.
Additionnally:

For cohort 1: severe renal failure (KDIGO stage ≥2) without CVVH AND SOFA score ≥4.
For cohort 2: severe renal failure (KDIGO stage ≥2) with CVVH AND sequential organ failure assessment (SOFA) score ≥4.
For cohort 3: no renal failure (creatinine clearance > 60 ml/min)

Exclusion criteria

Platelet count < 50 000/μl.
CHILD PUGH stage C cirrhosis.
Known coagulation disorder.
Patient treated in the last 3 days with direct oral anticoagulants.
Patient treated in the last 24h with LMWH before enrollment.
High bleeding risk with contra indication for standard dose of LMWH prophylaxis, as per investigator judgment
Indication for therapeutic anticoagulation (including CVVH with systemic heparin anticoagulation).
Body weight < 50 kg or > 120 kg.
Evidence of recovery of renal function before enrollment, based on investigator judgement.

Treatment and study plan

Anti-Xa profiles after the subcutaneous administration of a prophylactic dose of enoxaparin

Diagnostic Test

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.

Primary outcomes

mean peak anti-Xa activity

Time frame: 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin

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

Time frame: 0-24 hours after the subcutaneous administration of a prophylactic dose of enoxaparin
Trough value of anti-Xa activity

Time frame: Trough value of anti-Xa activity 24 hours after the injection of a prophylactic dose of enoxaparin.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas De Schryver, MD

CONTACT

[email protected]

+3210737251

Sponsors and collaborators

Lead sponsor

Clinique Saint Pierre Ottignies

Other

Registry information

Acronym: AKI-ENOXA

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 3, 2026
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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