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Pharmacokinetics of Enoxaparin in Intensive Care Patients

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital
  • Helsinki University Central Hospital, Meilahti

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Subcutaneous Enoxaparin

Intravenous Enoxaparin

Arm Description

Subcutaneous enoxaparin 40 mg every 24 hours for three days

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2014
Last Updated
October 26, 2017
Sponsor
Tampere University Hospital
Collaborators
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02095509
Brief Title
Pharmacokinetics of Enoxaparin in Intensive Care Patients
Official Title
Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
Collaborators
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous Enoxaparin
Arm Type
Active Comparator
Arm Description
Subcutaneous enoxaparin 40 mg every 24 hours for three days
Arm Title
Intravenous Enoxaparin
Arm Type
Active Comparator
Arm Description
40 mg enoxaparin daily as continuous intravenous infusion for three days (72 hours)
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Klexane (sanofi-Aventis Oy, Finland)
Intervention Description
Drug class: Low-molecular weight heparin
Primary Outcome Measure Information:
Title
Plasma anti-factor Xa level
Description
Change in plasma anti-factor Xa levels between baseline and 72 hours
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Incidence of Venous thromboembolism
Description
If clinically suspected a compression ultrasound will be done
Time Frame
90 days
Title
Incidence of Bleeding
Description
Major and minor bleeding events will be reported
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33521
Country
Finland
Facility Name
Helsinki University Central Hospital, Meilahti
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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Pharmacokinetics of Enoxaparin in Intensive Care Patients

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