Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics of Enoxaparin in Intensive Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02095509
Recruitment Status : Completed
First Posted : March 24, 2014
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Enoxaparin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients
Study Start Date : March 2014
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : September 30, 2016

Arm Intervention/treatment
Active Comparator: Subcutaneous Enoxaparin
Subcutaneous enoxaparin 40 mg every 24 hours for three days
Drug: Enoxaparin
Drug class: Low-molecular weight heparin
Other Name: Klexane (sanofi-Aventis Oy, Finland)

Active Comparator: Intravenous Enoxaparin
40 mg enoxaparin daily as continuous intravenous infusion for three days (72 hours)
Drug: Enoxaparin
Drug class: Low-molecular weight heparin
Other Name: Klexane (sanofi-Aventis Oy, Finland)




Primary Outcome Measures :
  1. Plasma anti-factor Xa level [ Time Frame: 72 hours ]
    Change in plasma anti-factor Xa levels between baseline and 72 hours


Secondary Outcome Measures :
  1. Incidence of Venous thromboembolism [ Time Frame: 90 days ]
    If clinically suspected a compression ultrasound will be done

  2. Incidence of Bleeding [ Time Frame: 90 days ]
    Major and minor bleeding events will be reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095509


Locations
Layout table for location information
Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33521
Helsinki University Central Hospital, Meilahti
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Tampere University Hospital
Helsinki University Central Hospital

Layout table for additonal information
Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02095509    
Other Study ID Numbers: 2012-004599-21
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases