Effective prevention of blood clots in critically ill patients - part 2
| ISRCTN | ISRCTN91570009 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91570009 |
| EudraCT/CTIS number | 2010-022034-88 |
| Secondary identifying numbers | EudraCT-number: 2010-022034-88 |
- Submission date
- 25/11/2010
- Registration date
- 14/03/2011
- Last edited
- 28/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Palle Toft
Scientific
Scientific
Department of Anaesthesia and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
Odense
DK 5000
Denmark
| palle.toft@ouh.regionsyddanmark.dk |
Study information
| Study design | Prospective randomised double-blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in the web format, please use the contact details below to request a patient information sheet |
| Scientific title | Enoxaparin - effective dosage for intensive care patients: a double-blinded, randomised clinical trial - part 2 |
| 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(s) | Local medical ethics committee (Den Videnskabsetisk Komite for Vejle og Fyn), 19/10/2010, project-ID: S-20100089 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Enoxaparin |
| Primary outcome measure | 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 study start date | 01/12/2010 |
| Overall study end date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 patients |
| 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 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
Study participating centre
Odense University Hospital
Odense
DK 5000
Denmark
DK 5000
Denmark
Sponsor information
Odense University Hospital (Denmark)
University/education
University/education
Department of Anaesthesia and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
Odense
DK 5000
Denmark
| ode.v.sekretariatet@ouh.regionsyddanmark.dk | |
| Website | http://www.ouh.dk/wm259883 |
"ROR" |
https://ror.org/00ey0ed83 |
Funders
Funder type
Research council
The Danish Society of Anaesthesiology and Intensive Medicines Research Initiative (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/04/2013 | Yes | No |
