Pharmacokinetics of Enoxaparin in Intensive Care Patients

NCT02095509 | Completed Phase 4

• 1 other identifier: 2012-004599-21
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Plasma anti-factor Xa level

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

  72 hours

Secondary Outcomes (2)

• Incidence of Venous thromboembolism

  90 days

• Incidence of Bleeding

  90 days

Study Arms (2)

Subcutaneous Enoxaparin

ACTIVE COMPARATOR

Subcutaneous enoxaparin 40 mg every 24 hours for three days

Drug: Enoxaparin

Intravenous Enoxaparin

ACTIVE COMPARATOR

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

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

Drug class: Low-molecular weight heparin

Also known as: Klexane (sanofi-Aventis Oy, Finland)

Intravenous Enoxaparin; Subcutaneous Enoxaparin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Helsinki University Central Hospital: collaborator

Study Sites (2)

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Helsinki University Central Hospital, Meilahti

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: September 30, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

FI (2)