Additional identifiers
EudraCT number
2005-002381-10
ClinicalTrials.gov number
Protocol/serial number
EudraCT: 2005-002381-10
Study information
Scientific title
Enoxaparin - effective dosage for intensive care patients: a double-blinded, randomised clinical trial
Acronym
Study hypothesis
Inadequate dosage of enoxaparin may be a possible explanation for the high failure rate of thromboembolic prophylaxis in intensive care unit (ICU) patients. The administration of higher doses of enoxaparin may give better anti-factor Xa levels in ICU patients and may thereby confer a greater degree of protection against venous thromboembolism.
Ethics approval
Local medical ethics committee (Den Videnskabsetisk Komite for Vejle og Fyn) approved on the 3rd June 2005 (ref: VF-2004-0225)
Study design
Prospective randomised double-blinded controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Venous thromboembolism
Intervention
Patients were randomised into four groups/arms to receive one of the following subcutaneous doses of enoxaparin (Clexane®): 40, 50, 60, or 70 mg for a period of 24 hours. Patients receiving 40 mg (the standard thromboprophylactic dose of enoxaparin) acted as the control group, while patients receiving 50, 60, and 70 mg were considered intervention groups. The total duration of treatment and follow-up was 24 hours.
Intervention type
Drug
Phase
Not Applicable
Drug names
Enoxaparin
Primary outcome measures
Peak anti-factor Xa levels (peak = 4 hours post-enoxaparin administration). Levels of anti-factor Xa activity were determined using a validated chromogenic assay kit (COAMATIC Heparin, Chromogenix, Instrumentation Laboratory Company, Lexington, USA) with the substrate S-2732, and the apparatus (STA-R Evolution, Diagnostica Stago, Asnieres, France).
Secondary outcome measures
1. Antithrombin (AT)
2. Prothrombin time (PT)
3. Activated partial thromboplastin time (aPTT)
4. Thrombin-antithrombin complexes (TAT), determined using an enzyme-immunoassay (Enzygnostâ TAT micro, Siemens, Marburg, Germany)
5. Fibrinogen
6. Platelets
7. D-dimer
Measured immediately before, and at 4, 12, and 24 hours after the administration of enoxaparin.
Overall trial start date
01/02/2006
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Consecutive patients admitted to the ICU
2. Aged over 18 years, either sex
3. Minimum stay of greater than 24 hours
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 patients
Participant exclusion criteria
1. Patients weighing less than 50 kg or greater than 90 kg
2. Bleeding diathesis
3. In need of an operation within the timeframe of the study
4. Pregnant
5. Requiring continuous veno-venous haemofiltration
Recruitment start date
01/02/2006
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Anaesthesia and Intensive Care
Odense
DK 5000
Denmark
Sponsor information
Organisation
Odense University Hospital (Denmark)
Sponsor details
Department of Anaesthesia and Intensive Care
Sdr. Boulevard 29.
Odense
DK 5000
Denmark
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Professor Sophus H Johansens Foundation (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Danielsens Foundation (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Danish Society of Anaesthesiology and Intensive Medicines Research Initiative (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary