Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients
Study Details
Study Description
Brief Summary
Objective: To compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of LMWH for thromboprophylaxis in critically ill patients
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intravenous group
|
Drug: Nadroparin (intravenous Infusion)
Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
|
Active Comparator: Subcutaneous group
|
Drug: Nadroparin (subcutaneous group)
Subcutaneous route of administration of nadroparin 3800 IU
|
Outcome Measures
Primary Outcome Measures
- 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
- 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) [0-24 hours]
Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin
Eligibility Criteria
Criteria
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
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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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Clinique Saint Pierre Ottignies
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IV vs SC LMWH ICU