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

Phase 4CompletedNCT04982055

Clinique Saint Pierre Ottignies60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Critical Illness

Interventions

Nadroparin (intravenous Infusion)DRUG

Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU

Nadroparin (subcutaneous group)DRUG

Subcutaneous route of administration of nadroparin 3800 IU

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Peak anti-Xa activity

Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration

Time frame: Peak anti-Xa activity obtained 4 hours after start of low molecular weight heparin administration

Secondary Outcomes

Trough anti-Xa activity

Trough anti-Xa activity measured 24 hours after start of low molecular weight administration

Time frame: 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

Time frame: 0-24 hours

Data from ClinicalTrials.gov

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