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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-08

Study Completion Date

2020-12-31

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

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravenous group

Group Type EXPERIMENTAL

Nadroparin (intravenous Infusion)

Intervention Type DRUG

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

Subcutaneous group

Group Type ACTIVE_COMPARATOR

Nadroparin (subcutaneous group)

Intervention Type DRUG

Subcutaneous route of administration of nadroparin 3800 IU

Interventions

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Nadroparin (intravenous Infusion)

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

Intervention Type DRUG

Nadroparin (subcutaneous group)

Subcutaneous route of administration of nadroparin 3800 IU

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No