Contact information
Type
Scientific
Primary contact
Dr J J Hofstra
ORCID ID
Contact details
Academic Medical Center (AMC)
IC Unit
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31(0)20 566 8224
J.J.Hofstra@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
NebHep study
Study hypothesis
We hypothesise that unfractionated heparin could be of benefit in treatment of Acute Lung Injury (ALI). Delivering heparin directly to the pulmonary compartment may attenuate fibrin depositions more effectively while reducing the risk of bleeding as a result of systemic anticoagulant effects. Intubated and mechanically ventilated patients may also benefit from such strategies since mechanical ventilation may cause injury very similar to ALI and pneumonia.
Before future investigations of therapeutic effects of nebulised unfractionated heparin in mechanically ventilated patients with ALI can be performed, this therapeutic strategy needs to be tested on its feasibility and safety. Therefore, in this study we will evaluate the feasibility and safety of treatment with inhaled heparin in intubated and mechanically ventilated patients without ALI. We consider treatment with inhaled heparin to be safe if none of the included patients show a more than 25% increase of area under the curve of serial anti-Xa measurements in plasma.
If treatment with inhaled heparin is safe, we will perform a new study in patients with ALI.
Ethics approval
Not provided at time of registration
Study design
Randomised, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mechanical ventilation
Intervention
Administration of unfractionated heparin or placebo by aerosol generator (AeronebPro, Aerogen Inc., Sunnyvale, CA, USA) during mechanical ventilation.
Blood samples and lung fluid will be collected before treatment and at one, three, six and 24 hours after the beginning of the last nebulisation.
Intervention type
Drug
Phase
Not Specified
Drug names
Unfractionated heparin
Primary outcome measures
Area under the curve of serial anti-Xa measurements in plasma.
Secondary outcome measures
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, 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)
2. Occurrence and severity of bleeding events
Overall trial start date
01/02/2007
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients who are mechanically ventilated
2. Aged more than 18 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
24
Participant 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
Recruitment start date
01/02/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary