Medical-surgical Intensive Care Unit (ICU) patients Surgery Medical-surgical patients
Conditions
Interventions
LMWH (dalteparin 5000 IU once daily and placebo once daily) or UFH (5000 IU twice daily).
Sponsors
McMaster University Medical Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Admission to Intensive Care Unit (ICU) 2. Either sex, 18 years of age or over 3. Expected ICU admission more than or equal to 72 hours
Exclusion criteria
Exclusion criteria: 1. Diagnosis of trauma, post-orthopedic surgery, or neurosurgery at ICU admission 2. Severe hypertension (systolic blood pressure more than or equal to 180 mmHg for two hours or more) at ICU admission. Intracranial haemorrhage at ICU admission or within three months. 3. Known deep vein thrombosis (DVT), pulmonary embolism (PE) or major haemorrhage at ICU admission. Coagulopathy (defined as international normalised ratio [INR] values more than or equal to two times upper limit of normal). 4. Platelet count more than or equal to 50 x 10^9/l. Current therapeutic oral or intravenous anticoagulation for any reason. Current administration of activated protein. Estimated creatinine clearance less than or equal to 30 ml/min. 5. History of allergy to heparin or heparin-induced thrombocytopenia (HIT) 6. Receipt more than or equal to two doses of either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) in ICU or Critical Care Unit (CCU) 7. Pregnancy 8. Limitation of life support or palliative care 9. No informed consent 10. Prior enrolment in this trial or currently in another related randomised trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scientific: To establish the effect of LMWH versus UFH on DVT rates in medical-surgical ICU patients. Feasibility: 1. The feasibility of timely enrolment and complete, blinded study drug administration 2. The bioaccumulation of LMWH in patients with acquired renal insufficiency and its association with bleeding 3. The feasibility of scheduled twice weekly lower limb ultrasounds 4. Recruitment rates for a future randomised trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Scientific: Among medical-surgical ICU patients, to establish the effect of LMWH versus UFH: 1. On PE (PE diagnosed by the PE diagnosis algorithm) 2. On bleeding events 3. On anti-Xa levels, and thus, the need for dose adjustment 4. On thrombocytopenia and heparin-induced thrombocytopenia | — |
Countries
Australia, Canada, Singapore, United States of America
Outcome results
None listed