Pharmacokinetics of Enoxaparin in Intensive Care Patients

• Status: Completed
• Trial end date: 2016-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampere University Hospital
• Collaborator: Helsinki University Central Hospital
• Treatments: Enoxaparin

Criteria

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