The effect of inhaled heparin on pulmonary coagulation activation and vascular permeability in mechanically ventilated patients with acute lung injury / acute respiratory disress syndrome

Phase 2

Conditions: acute lung injury
pneumonia
10038716

Registration Number: NL-OMON31496

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

All patients who are intubated and mechanically ventilated in the ICU, who meet the International Consensus Criteria of ALI/ARDS
Inclusion Criteria:
-Informed consent
-Age 18-80 years
-Recent onset of ALI/ARDS (i.e. <48 hrs)

Exclusion Criteria

Exclusion criteria
-Acute bleeding at any site
-Increased risk of bleeding:
•Platelets< 50 * 109 / L
•PT > 20 sec
•APTT > 60 sec
•Within 24 hours after major surgery
-Proven of clinically suspected heparin induced thrombocytopenia
-Hemorrhagic diathesis
-Heparin allergy
-Pregnancy or breast feeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>TATc in BAL fluid<br /><br>PLI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• LIS<br /><br>• In blood: TF, TFPI activity, TFPI antigen, Factor VII/VIIa, protein C /<br /><br>activated protein C, prothrombin fragment 1.2, TATc, endogenous thrombin<br /><br>potential, fibrin monomers, soluble thrombomodulin, PAPc, PAI.<br /><br>• In BAL fluid: TF, TFPI activity, TFPI antigen, Factor VII/VIIa, protein C /<br /><br>activated protein C, prothrombin fragment 1.2, TATc, endogenous thrombin<br /><br>potential, fibrin monomers, soluble thrombomodulin, PAPc, PAI.<br /><br>• Occurrence and severity of bleeding events </p><br>