Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients

Study Overview
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Brief Summary
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Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients

Detailed Description
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The study is a prospective, monocentric, randomized trial. Patients are randomized to the IV route of administration over a 4-hours infusion of nadroparin 3800 IU or to the SC route of administration. Randomization is stratified according to the need for vasopressor or not. Anti-Xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.

Official Title
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Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Nadroparin (intravenous Infusion)
* Drug: Nadroparin (subcutaneous group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults patients > 18 years old admitted in the ICU, and for whom thromboprophylaxis is indicated Exclusion Criteria: renal failure determined by glomerular filtration rate (GFR) < 30 ml/min or need for renal replacement therapy liver cirrhosis intravascular disseminated coagulation contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,…) patients receiving low dose of vasopressor (norepinephrine < 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous group<br> | Drug: Nadroparin (intravenous Infusion)<br>* Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU<br>|
| Active Comparator: Subcutaneous group<br> | Drug: Nadroparin (subcutaneous group)<br>* Subcutaneous route of administration of nadroparin 3800 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak anti-Xa activity | Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration | Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough anti-Xa activity | Trough anti-Xa activity measured 24 hours after start of low molecular weight administration | Trough anti-Xa activity measured 24 hours after start of low molecular weight administration | 
| AUC (0-24h) | Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin | 0-24 hours |