Pharmacokinetics of Enoxaparin in Intensive Care Patients

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095509
• Other study ID #: 2012-004599-21
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2014
• Last updated: October 26, 2017
• Start date: March 2014
• Est. completion date: September 30, 2016

Study information

• Verified date: October 2017
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Enoxaparin
Drug class: Low-molecular weight heparin

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Meilahti	Helsinki	Uusimaa
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma anti-factor Xa level	Change in plasma anti-factor Xa levels between baseline and 72 hours	72 hours
Secondary	Incidence of Venous thromboembolism	If clinically suspected a compression ultrasound will be done	90 days
Secondary	Incidence of Bleeding	Major and minor bleeding events will be reported	90 days