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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint Pierre Ottignies

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Thromboprophylaxis armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

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

Secondary outcomes

1

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
2

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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