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OpenTrials
Completed

NCT Number: NCT04982055

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Peak anti-Xa activity

    Time frame: 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 outcomes

  1. Trough anti-Xa activity

    Time frame: 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

  2. AUC (0-24h)

    Time frame: 0-24 hours

    Area under the curve 0-24 hours of anti-Xa activity after start of low molecular weight heparin

Sponsors and collaborators

Lead sponsor

Clinique Saint Pierre Ottignies

Other

Registry information

Official study title

Intravenous Versus Subcutaneous Administration of Low Molecular Weight Heparin for Thromboprophylaxis in Critically Ill Patients: a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2021
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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