Feasibility and safety of inhaled heparin in intubated and mechanically ventilated patients: a randomised controlled trial comparing three doses of inhaled unfractionated heparin
| ISRCTN | ISRCTN28587216 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28587216 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 22/01/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J J Hofstra
Scientific
Scientific
Academic Medical Center (AMC)
IC Unit
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31(0)20 566 8224 |
|---|---|
| J.J.Hofstra@amc.uva.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | NebHep study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Unfractionated heparin |
| Primary outcome measure | 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 study start date | 01/02/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Patients who are mechanically ventilated 2. Aged more than 18 years |
| Key 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 |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
