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

Phase 4

Completed

• Conditions: Critical Illness
• Interventions: Drug: Nadroparin (intravenous Infusion); Drug: Nadroparin (subcutaneous group)

• Registration Number: NCT04982055
• Lead Sponsor: Clinique Saint Pierre Ottignies

Brief Summary

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

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 Timeline

• Study Start: 2015-04-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-29
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous group	Nadroparin (intravenous Infusion)	-
Subcutaneous group	Nadroparin (subcutaneous group)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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