Welcome
Support Centre
25 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Effective prevention of blood clots in critically ill patients - part 2
ISRCTN ISRCTN91570009
DOI 10.1186/ISRCTN91570009
ClinicalTrials.gov identifier
EudraCT number 2010-022034-88
Public title Effective prevention of blood clots in critically ill patients - part 2
Scientific title Enoxaparin - effective dosage for intensive care patients: a double-blinded, randomised clinical trial - part 2
Acronym N/A
Serial number at source EudraCT-number: 2010-022034-88
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.

The first part of our study supported the earlier finding that 40 mg enoxaparin subcutaneously once daily was insufficient for the prevention of venous thromboembolism. The study also pointed to inadequate dose and not the route of administration or disease severity, as the possible explanation for the low anti-Xa activity measured after enoxaparin administration in intensive care patients. These findings require further investigation.
Lay summary
Ethics approval Local medical ethics committee (Den Videnskabsetisk Komite for Vejle og Fyn) approved the study on the 19 October 2010 (project-ID: S-20100089 )
Study design Prospective randomised double-blinded controlled trial
Countries of recruitment Denmark
Disease/condition/study domain Venous thromboembolism
Participants - inclusion criteria 1. Consecutive patients admitted to the ICU
2. Aged over 18 years, either sex
3. Minimum stay of greater than 24 hours
Participants - 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
Anticipated start date 01/12/2010
Anticipated end date 01/12/2011
Status of trial Completed
Patient information material Not available in the web format, please use the contact details below to request a patient information sheet
Target number of participants 80 patients
Interventions Patients will be randomly assigned to four groups by sequentially numbered sealed envelopes to receive one of the following subcutaneous doses of enoxaparin (Clexane®): 40 mg x1, 30mg x2 , 40mg x2 or 1mg/kg x1 for a period of 72 hours. Patients receiving 40 mg (the standard thromboprophylactic dose of enoxaparin) will act as the control group, while patients receiving 30mg x2, 40mg x2 , and 1mg/kg x1 are considered intervention groups. The total duration of treatment and follow-up will be 72 hours.
Primary outcome measure(s) Peak anti-factor Xa levels (peak = 4 hours post-enoxaparin administration). Levels of anti-factor Xa activity will be 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 measure(s) 1. Antithrombin (AT)
2. Fibrinogen
3. Platelets
4. D-dimer

Measured immediately before, and at 4, 12, 16 and 24 hours after the administration of enoxaparin.
Sources of funding The Danish Society of Anaesthesiology and Intensive Medicines Research Initiative (Denmark)
Trial website
Publications
Contact name Prof  Palle  Toft
  Address Department of Anaesthesia and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
  City/town Odense
  Zip/Postcode DK 5000
  Country Denmark
  Email palle.toft@ouh.regionsyddanmark.dk
Sponsor Odense University Hospital (Denmark)
  Address Department of Anaesthesia and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
  City/town Odense
  Zip/Postcode DK 5000
  Country Denmark
  Email ode.v.sekretariatet@ouh.regionsyddanmark.dk
  Sponsor website: http://www.ouh.dk/wm259883
Date applied 25/11/2010
Last edited 18/03/2011
Date ISRCTN assigned 14/03/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.