Pharmacokinetics of Enoxaparin in Intensive Care Patients

Phase 4

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Enoxaparin

• Registration Number: NCT02095509
• Lead Sponsor: Tampere University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-24
• Primary Completion: 2016-06-30
• Study Completion: 2016-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous Enoxaparin	Enoxaparin	Subcutaneous enoxaparin 40 mg every 24 hours for three days
Intravenous Enoxaparin	Enoxaparin	40 mg enoxaparin daily as continuous intravenous infusion for three days (72 hours)

Primary Outcome Measures

Name	Time	Method
Plasma anti-factor Xa level	72 hours	Change in plasma anti-factor Xa levels between baseline and 72 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of Venous thromboembolism	90 days	If clinically suspected a compression ultrasound will be done
Incidence of Bleeding	90 days	Major and minor bleeding events will be reported

Trial Locations

Locations (2)

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland

Helsinki University Central Hospital, Meilahti; 🇫🇮 Helsinki, Uusimaa, Finland