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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous group | Experimental |
| |
| Subcutaneous group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin (intravenous Infusion) | Drug | Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35381407 | Derived | De Schryver N, Serck N, Eeckhoudt S, Laterre PF, Wittebole X, Gerard L. Pharmacokinetic profiles of intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients: A randomized controlled trial. J Crit Care. 2022 Aug;70:154029. doi: 10.1016/j.jcrc.2022.154029. Epub 2022 Apr 2. |
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| Nadroparin (subcutaneous group) | Drug | Subcutaneous route of administration of nadroparin 3800 IU |
|
Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin
| 0-24 hours |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
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