Effective prevention of blood clots in critically ill patients
| ISRCTN | ISRCTN03037804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03037804 |
| EudraCT/CTIS number | 2005-002381-10 |
| Secondary identifying numbers | EudraCT: 2005-002381-10 |
- Submission date
- 03/02/2010
- Registration date
- 22/02/2010
- Last edited
- 16/05/2019
- 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 of protocol
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
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 |
| Scientific title | Enoxaparin - effective dosage for intensive care patients: a double-blinded, randomised clinical trial |
| Study objectives | 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(s) | Local medical ethics committee (Den Videnskabsetisk Komite for Vejle og Fyn) approved on the 3rd June 2005 (ref: VF-2004-0225) |
| Health condition(s) or problem(s) studied | 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 |
| 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 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 study start date | 01/02/2006 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 patients |
| Key inclusion criteria | 1. Consecutive patients admitted to the ICU 2. Aged over 18 years, either sex 3. Minimum stay of greater than 24 hours |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Anaesthesia and Intensive Care
Odense
DK 5000
Denmark
DK 5000
Denmark
Sponsor information
Odense University Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesia and Intensive Care
Sdr. Boulevard 29.
Odense
DK 5000
Denmark
| Website | http://www.ouh.dk/wm259883 |
|---|---|
"ROR" |
https://ror.org/00ey0ed83 |
Funders
Funder type
Charity
Professor Sophus H Johansens Foundation (Denmark)
No information available
Danielsens Foundation (Denmark)
No information available
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? |
|---|---|---|---|---|---|
| Basic results | 16/05/2019 | No | No |
Editorial Notes
16/05/2019: Added clinicaltrialsregister.eu link to basic results (scientific).
