Condition category
Respiratory
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
22/01/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes