Feasibility and Safety of Inhaled Heparin in Intubated and Mechanically Ventilated Patients: A Randomized Controlled Trial Comparing Three Doses of Inhaled Unfractionated Heparin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27158

Enrollment

Registered

2006-12-07

Start date

2007-02-01

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

Mechanically ventilated patients without ALI

Interventions

Administration of unfractionated heparin or placebo by aerosol generator (AeronebPro, Aerogen Inc., Sunnyvale, CA, USA) during mechanical ventilation. Bloodsamples and lungfluid will be collected bef

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are mechanically ventilated; 2. Age > 18 years.

Exclusion criteria

Exclusion criteria: 1. Acute Lung Injury (consensus criteria); 2. Increased risk of bleeding: a. Within 24 hours after major surgery; b. Thrombocytes 20 sec; d. APTT > 60 sec; 3. Acute bleeding at any site; 4. Pregnancy or breast feeding.

Design outcomes

Primary

Measure	Time frame
Area under the curve of serial anti-Xa measurements in plasma.	—

Secondary

Measure	Time frame
1. Blood: a. Area under the cure of serial aPTT measurements; b. Whole blood clotting time lung fluid: 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; 2. Occurrence and severity of bleeding events.	—

Measure

Time frame

1. Blood: a. Area under the cure of serial aPTT measurements; b. Whole blood clotting time lung fluid: 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; 2. Occurrence and severity of bleeding events.

—

Contacts

Public ContactJ.J. Hofstra

Academic Medical Center (AMC) IC Unit, P.O. Box 22660

J.J.Hofstra@amc.uva.nl+31(0)20 5668224

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)