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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thromboprophylaxis arm | Experimental | Participating subjects will be given a prophylactic dose of enoxaparin, via the subcutaneous route, as standard of care. The enoxaparin dose will be defined according to the actual patient's body weight as follow: 40 mg daily for patients between 60 and 100 kg, 30 mg daily for patient < 60 kg and 50 mg daily for patients > 100 kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 hours after the subcutaneous administration of a prophylactic dose of enoxaparin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean area under the curve (AUC) (0-24 hours) of anti-Xa activity | 0-24 hours after the subcutaneous administration of a prophylactic dose of enoxaparin | |
| Trough value of anti-Xa activity | Trough value of anti-Xa activity 24 hours after the injection of a prophylactic dose of enoxaparin. |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas De Schryver, MD | Contact | +3210737251 | nicolas.deschryver@cspo.be |
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There is no intention to share IPD for this trial.
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|
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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