Feasibility and Safety of Inhaled Heparin in Intubated and Mechanically Ventilated Patients: A Randomized Controlled Trial Comparing Three Doses of Inhaled Unfractionated Heparin.
- Conditions
- Mechanically ventilated patients without ALI
- Registration Number
- NL-OMON27158
- Lead Sponsor
- Academic Medical Centre, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Patients who are mechanically ventilated;
2. Age > 18 years.
Exclusion Criteria
1. Acute Lung Injury (consensus criteria);
2. Increased risk of bleeding:
a. Within 24 hours after major surgery;
b. Thrombocytes < 50 * 109 / L;
c. PT > 20 sec;
d. APTT > 60 sec;
3. Acute bleeding at any site;
4. Pregnancy or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of serial anti-Xa measurements in plasma.
- Secondary Outcome Measures
Name Time Method 1. Blood:<br>a. Area under the cure of serial aPTT measurements;<br>b. Whole blood clotting time lung fluid:<br>area under the curve of serial anti-Xa measurements, heparin, factor VII/VIIa, TF, TFPI-antigen, TFPI activity, protein C / activated protein C, prothrombine fragment 1.2, TATc, ETP (Endogenous Thrombin Potential), Fibrin monomers, soluble thrombomodulin, PAPc, PAI;<br>2. Occurrence and severity of bleeding events.