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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31496

Enrollment

Registered

2008-05-27

Start date

2007-02-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute lung injury pneumonia

Interventions

Patients will receive 4 nebulizations of either 4 mL unfractionated heparin (ie 100,000 IU) or 4 mL placebo (ie 0.9% NaCl) depending on randomisation, in a timeframe of 24 hours.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Exclusion criteria -Acute bleeding at any site -Increased risk of bleeding: •Platelets 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

Design outcomes

Primary

Measure	Time frame
TATc in BAL fluid PLI	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)