The HEPALI Study

The effects of inhaled heparin on pulmonary coagulation activation and vascular permeability in mechanically ventilated patients with Acute Lung Injury / Acute Respiratory Distress Syndrome.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28056

Enrollment

Registered

2007-10-30

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

1. Acute Lung Injury

Interventions

Nebulization of heparin (100,000 IU) or placebo every 8 hrs during 24 hrs. Before the first and after the last nebulization bronchoscopy will be performed to obtain bronchoalveolar lavage fluid of bot

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria All patients being intubated and mechanically ventilated in the ICU, who meet the International Consensus Criteria of ALI or ARDS: 1. Informed consent; 2. Age: 18-80 years; 3. Recent onset of ALI or ARDS (i.e. <48 hrs).

Exclusion criteria

Exclusion criteria: 1. Acute bleeding at any site; 2. Increased risk of bleeding: Thrombocytes 60 sec PT > 20 sec, or INR > 1.7; 3. Within 24 hours after major surgery; 4. Proven or clinically suspected heparin induced thrombocytopenia; 5. Hemorrhagic diathesis; 6. Heparin allergy; 7. Pregnancy or breast feeding.

Design outcomes

Primary

Measure	Time frame
1. TATc in BAL fluid; 2. PLI.	—

Secondary

Measure	Time frame
1. LIS; 2. 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; 3. 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; 4. Occurrence and severity of bleeding events.	—

Measure

Time frame

1. LIS; 2. 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; 3. 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; 4. Occurrence and severity of bleeding events.

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Contacts

Public ContactA.D. Cornet

De Boelelaan 1117, kamer ZH 7D112

cornet@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)