Condition category
Circulatory System
Date applied
25/11/2010
Date assigned
14/03/2011
Last edited
28/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Palle Toft

ORCID ID

Contact details

Department of Anaesthesia and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
Odense
DK 5000
Denmark
-
palle.toft@ouh.regionsyddanmark.dk

Additional identifiers

EudraCT number

2010-022034-88

ClinicalTrials.gov number

Protocol/serial number

EudraCT-number: 2010-022034-88

Study information

Scientific title

Enoxaparin - effective dosage for intensive care patients: a double-blinded, randomised clinical trial - part 2

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.

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.

Ethics approval

Local medical ethics committee (Den Videnskabsetisk Komite for Vejle og Fyn), 19/10/2010, project-ID: S-20100089

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

Not available in the web format, please use the contact details below to request a patient information sheet

Condition

Venous thromboembolism

Intervention

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.

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 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 measures

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.

Overall trial start date

01/12/2010

Overall trial end date

01/12/2011

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

01/12/2010

Recruitment end date

01/12/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

Odense University Hospital
Odense
DK 5000
Denmark

Sponsor information

Organisation

Odense University Hospital (Denmark)

Sponsor details

Department of Anaesthesia and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
Odense
DK 5000
Denmark
-
ode.v.sekretariatet@ouh.regionsyddanmark.dk

Sponsor type

University/education

Website

http://www.ouh.dk/wm259883

Funders

Funder type

Research council

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23601744

Publication citations

Additional files

Editorial Notes