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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR849 |
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Date of registration:
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07/12/2006 |
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Primary sponsor: |
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Public title:
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Feasibility and Safety of Inhaled Heparin in Intubated and Mechanically Ventilated Patients: A Randomized Controlled Trial Comparing Three Doses of Inhaled Unfractionated Heparin.
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Scientific title:
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Feasibility and Safety of Inhaled Heparin in Intubated and Mechanically Ventilated Patients: A Randomized Controlled Trial Comparing Three Doses of Inhaled Unfractionated Heparin. - NebHep study |
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Date of first enrolment:
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1/2/2007 |
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Target sample size:
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24 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=849 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Placebo; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J.J.
Hofstra |
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Address:
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Academic Medical Center (AMC)
IC Unit,
P.O. Box 22660, Meibergdreef 9
IC Unit, C3-423
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 5668224 |
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Email:
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J.J.Hofstra@amc.uva.nl |
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Affiliation:
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Name:
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J.J.
Hofstra |
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Address:
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Academic Medical Center (AMC)
IC Unit,
P.O. Box 22660, Meibergdreef 9
IC Unit, C3-423
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 5668224 |
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Email:
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J.J.Hofstra@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients who are mechanically ventilated;
2. Age > 18 years.
Exclusion criteria: 1. Acute Lung Injury (consensus criteria);
2. Increased risk of bleeding:
a. Within 24 hours after major surgery;
b. Thrombocytes < 50 * 109 / L;
c. PT > 20 sec;
d. APTT > 60 sec;
3. Acute bleeding at any site;
4. Pregnancy or breast feeding.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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Administration of unfractionated heparin or placebo by aerosol generator (AeronebPro, Aerogen Inc., Sunnyvale, CA, USA) during mechanical ventilation. Bloodsamples and lungfluid will be collected before treatment and at 1, 3, 6 and 24 hours after the beginning of the last nebulization
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Primary Outcome(s)
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Area under the curve of serial anti-Xa measurements in plasma.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN28587216
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC)
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