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OpenTrials
Completed

NCT Number: NCT02095509

Pharmacokinetics of Enoxaparin in Intensive Care Patients

To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily.

To investigate possible ongoing coagulation by coagulation markers during antithrombotic therapy with standard doses of enoxaparin

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital, Tampere, Pirkanmaa, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body Mass Index between 18-30 kg/m2
  • Critically ill patients requiring intensive care and pharmacological thromboprophylaxis
  • Expected to remain in the ICU for at least 72 h
  • Written informed consent obtained from the patient or his/her legal representative.

Exclusion criteria

  • Other indications for anticoagulant therapy than thromboprophylaxis
  • Intracranial haemorrhage or central neurosurgical operation within three months prior to the admission
  • Disseminated intravascular coagulation (DIC) according to the international society on Thrombosis and Haemostasis criteria
  • Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
  • Treatment with enoxaparin or any other low-molecular weight heparin (LMWH) or heparin within 24 hours prior to ICU admission. If patient has received thromboprophylactic dose of LMWH within 24-72 hours before ICU admission inclusion can be done if measured anti-factor Xa level is <0.1 IU/ml at the time of admission
  • Any long-term anticoagulant medication, expect low-dose aspirin
  • Major bleeding within the last week unless definitively treated
  • Blood platelet count <50, P-thromboplastin time (TT) <40% , international normalized ratio (INR) >1.7
  • Glomerular filtration rate less than 50 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation or chronic dialysis
  • HIV, hepatitis B virus, or hepatitis C virus infection
  • Pregnancy

Treatment and study plan

Enoxaparin

Drug

Drug class: Low-molecular weight heparin

Other names: Klexane (sanofi-Aventis Oy, Finland)

Primary outcomes

  1. Plasma anti-factor Xa level

    Time frame: 72 hours

    Change in plasma anti-factor Xa levels between baseline and 72 hours

Secondary outcomes

  1. Incidence of Venous thromboembolism

    Time frame: 90 days

    If clinically suspected a compression ultrasound will be done

  2. Incidence of Bleeding

    Time frame: 90 days

    Major and minor bleeding events will be reported

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Official study title

Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2014
Registry last updated
Oct 27, 2017

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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