Feasibility and safety of inhaled heparin in intubated and mechanically ventilated patients: a randomised controlled trial comparing three doses of inhaled unfractionated hepari
Completed
- Conditions
- Mechanical ventilationRespiratoryRespiratory distress
- Registration Number
- ISRCTN28587216
- Lead Sponsor
- Academic Medical Center (AMC) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Patients who are mechanically ventilated
2. Aged more than 18 years
Exclusion Criteria
1. Acute Lung Injury (consensus criteria)
2. Increased risk of bleeding:
a. Within 24 hours after major surgery
b. Thrombocytes less than 50 x 10^9/L
c. Prothrombin Time (PT) more than 20 seconds
d. Activated Partial Thromboplastin Time (APTT) more than 60 secconds
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, Tissue Factor (TF), Tissue Factor Pathway Inhibitor (TFPI)-antigen, TFPI activity, protein C/activated protein C, prothrombin fragment 1.2, Thrombin-AntiThrombin III complex (TATc), Endogenous Thrombin Potential (ETP), Fibrin monomers, soluble thrombomodulin, Plasmin-AntiPlasmin complexes (PAPc), Plasminogen Activator Inhibitor (PAI)<br>2. Occurrence and severity of bleeding events