Pharmacokinetics of Enoxaparin in Intensive Care Patients

NCT ID: NCT02095509

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-09-30

Brief 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

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Subcutaneous Enoxaparin

Subcutaneous enoxaparin 40 mg every 24 hours for three days

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Drug class: Low-molecular weight heparin

Intravenous Enoxaparin

40 mg enoxaparin daily as continuous intravenous infusion for three days (72 hours)

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Drug class: Low-molecular weight heparin

Interventions

Enoxaparin

Drug class: Low-molecular weight heparin

Intervention Type: DRUG

Other Intervention Names

Klexane (sanofi-Aventis Oy, Finland)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Helsinki University Central Hospital, Meilahti

Helsinki, Uusimaa, Finland

Countries

Finland

Other Identifiers

2012-004599-21

Identifier Type: -

Identifier Source: org_study_id