PROTECT - Prophylaxis of ThromboEmbolism in Critical Care Trial - PROTECT
- Conditions
- Critically ill patients who require admission to the intensive care unit and need pharmacologic thromboprophylaxis
- Registration Number
- EUCTR2009-012387-13-GB
- Lead Sponsor
- McMaster University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3650
Inclusion Criteria:
1.Men or women >18 years of age
2. Actual body weight >45 kg
3.Admission to intensive care unit expected to be >72 hours duration
4. Eligible for either unfractionated heparin or low molecular weight heparin thromboprophylaxis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Contraindication to prophylactic heparin
1.Neurosurgery within last 3 months
2.Ischemic or hemorrhagic stroke within last 3 months
3.Intracranial hemorrhage, within last 3 months
4.Systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg for > 12 hours requiring vasoactive drug infusion
5.Major hemorrhage within the last week unless definitively treated
6.Coagulopathy (INR > 2 x ULN, or PTT > 2 x ULN)
7.Thrombocytopenia
8. Other heparin contraindications (e.g., HIT, pregnancy)
9.Contraindications to blood products (e.g., Jehovah’s Witness)
10.Unable to perform lower limb ultrasound (e.g., severe distal extremity burns)
11. Limitation of life support (life expectancy < 7 days, or palliative care
12.Contamination (e.g., > 3 days of any heparin prophylaxis during this ICU admission)
13.Patient or substitute decision maker (SDM) declines consent
14.Patient unable to give consent and no SDM available
15.Randomized previously in PROTECT or related RCT
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of low molecular weight heparin versus unfractionated heparin on the primary outcome of proximal leg deep vein thrombosis diagnosed by compression ultrasound.;Secondary Objective: To evaluate the effect of low molecular weight heparin versus unfractionated heparin on the secondary outcomes of pulmonary embolism, bleeding, heparin-induced thrombocytopenia, and objectively confirmed venous thrombosis at any site. In addition, length of stay in the intensive care unit (ICU), ICU mortality, hospital length of stay and hospital mortality will be recorded.<br>;Primary end point(s): Proximal deep vein thrombosis (symptomatic or asymptomatic) diagnosed by bilateral lower extremity compression ultrasound.
- Secondary Outcome Measures
Name Time Method