Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma (Hepburn)
This study is not yet open for participant recruitment.
Verified January 2013 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator:
Dutch Burns Foundation
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01773083
First received: January 16, 2013
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
The purpose of this international multi-center double-blind randomized placebo-controlled trial is to determine the effect of nebulized heparin, compared to placebo, on the number of ventilator-free days at day 28, in burn patients with confirmed inhalation trauma requiring mechanical ventilation.
| Condition | Intervention | Phase |
|---|---|---|
|
Inhalation Injury Burn Injury |
Drug: unfractionated heparin Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn) |
Resource links provided by NLM:
Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Primary Outcome Measures:
- Number of ventilator-free days at day 28 [ Time Frame: at day 28 ] [ Designated as safety issue: No ]The number of ventilator-free days is defined as the number of days a patient is breathing without assist of a ventilator during the first 28 days; thus, the patient must be free of mechanical ventilation for 24 hours to have one ventilator-free day; if after successful detubation the patient requires a reintubation due to a surgical procedure, this reintubation will not count as a ventilator day - however, the day(s) will be counted as ventilator day(s) if mechanical ventilation is prolonged after surgery due to respiratory insufficiency.
Secondary Outcome Measures:
- Clinical outcome parameters [ Time Frame: daily or at day 28 and day 90 ] [ Designated as safety issue: No ]Clinical outcome parameters will include but not be restricted to: (a) length of stay (ICU and hospital); (b) mortality (28- and 90 days); (c) mortality (ICU and hospital); (d) daily Lung Injury Score (LIS); (e) daily Oxygenation Index (OI) ; (f) daily Sequential Organ Failure Assessment (SOFA)-scores ; (g) cumulative dosages of sedatives; (h) incidence of Ventilator-associated Pneumonia (VAP); (i) total number of bronchoscopy-guided cleaning of the larger airway
- Laboratory outcome parameters [ Time Frame: Blood and lavage samples: on admission day and every other day for a maximum period of 14 days ] [ Designated as safety issue: No ]Levels of markers of coagulation and fibrinolysis in blood and lung lavage fluid, Levels of markers of inflammation in blood and lung lavage fluid, Biomarkers of lung injury in blood and lung lavage fluid
- Safety parameters [ Time Frame: daily, for a maximum period of 28 days ] [ Designated as safety issue: Yes ]Safety parameters will include but not be restricted to: Occurrence of serious bleedings, any other transfusion of blood products - red cells and/or platelets and/or plasma, Confirmed Heparin induced thrombocytopenia, prolonged activated partial thromboplastin time (aPTT > 150 seconds)
| Estimated Enrollment: | 116 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: unfractionated heparin
25.000 IU/5 ml, will be nebulized 4 hourly (i.e. 6 times daily)
|
Drug: unfractionated heparin
nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days
Other Names:
|
|
Placebo Comparator: placebo
Sterile sodium chloride (NaCl 0.9%, Pfizer), in 5 ml, will be nebulized every 4 hours (i.e. 6 times daily)
|
Drug: placebo
Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days
Other Name: sterile sodium chloride (NaCl 0.9%)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent
- Age > 18 years
- Need for invasive mechanical ventilation
- Confirmed inhalation trauma (bronchoscopically)
Exclusion Criteria:
- > 36 hours after trauma
- Receiving invasive ventilation > 24 hours
- Expected duration of mechanical ventilation < 24 hours
- Chronic obstructive pulmonary disease GOLD stage III and IV
- Any history of pulmonary hemorrhage in the past 3 months
- Any history of significant bleeding disorder
- Known allergy to heparin, including heparin-induced thrombocytopenia
- Pregnancy or breast feeding
- Unlikely to survive for > 72 hours
- Total body surface area (TBSA) > 60%
- Witnessed or proven aspiration (i.e., confirmed by bronchoscopy)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773083
Contacts
| Contact: Gerie J Glas, MD | 00 31 20 5668222 | g.j.glas@amc.uva.nl |
| Contact: Koenraad F van der Sluijs, Dr. | 00 31 20 5669111 | KvanderSluijs@amc.uva.nl |
Locations
| Australia, Victoria | |
| St Vincent's Hospital | Not yet recruiting |
| Melbourne, Victoria, Australia, 3065 | |
| Contact: Barry Dixon, MD barry.dixon@svhm.org.au | |
| Principal Investigator: Barry Dixon, MD | |
| Belgium | |
| University Hospital, Gent | Not yet recruiting |
| Gent, Oost-Vlaanderen, Belgium, 9000 | |
| Contact: Kirsten | |
| Contact: Colpaert, MD, Dr. kirsten.colpaert@ugent.be | |
| Principal Investigator: Kirsten Colpaert, MD, Dr. | |
| University Hospital Gasthuisberg - Leuven | Not yet recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
| Contact: Jan Muller, MD jan.muller@uzleuven.be | |
| Principal Investigator: Jan Muller, MD | |
| Ziekenhuis Netwerk Antwerpen- Stuivenberg | |
| Antwerpen, Belgium, 2000 | |
| Netherlands | |
| Academic Medical Center | Not yet recruiting |
| Amsterdam, Noord-Holland, Netherlands, 1105 AZ | |
| Principal Investigator: Marcus J Schultz, Prof. Dr. | |
| Sub-Investigator: Koenraad F van der Sluijs, Dr. | |
| Sub-Investigator: Gerie J Glas, MD | |
| Sub-Investigator: Marcel M Levi, Prof. Dr. | |
| Sub-Investigator: Nicole P Juffermans, Dr. MD | |
| Red Cross Hospital, Beverwijk, the Netherlands | Not yet recruiting |
| Beverwijk, Noord-Holland, Netherlands, 1942 LE | |
| Contact: Paul Knape, MD pknape@rkz.nl | |
| Contact: David P Mackie, MD sd.mackie@wxs.nl | |
| Principal Investigator: Paul Knape, MD | |
| Sub-Investigator: David P Mackie, MD | |
| Maasstad Hospital | Not yet recruiting |
| Rotterdam, Zuid-Holland, Netherlands, 3079 DZ | |
| Contact: Barry Cleffken, MD cleffkenb@maasstadziekenhuis.nl | |
| Principal Investigator: Barry Cleffken, MD | |
| Martini Hospital | Not yet recruiting |
| Groningen, Netherlands, 9728 NT | |
| Contact: Bert G Loef, MD b.loef@mzh.nl | |
| Principal Investigator: Bert G Loef, MD, Dr. | |
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Burns Foundation
Investigators
| Principal Investigator: | Marcus J Schultz, Prof. Dr., MD | Academic Medical Center, Amsterdam |
| Study Director: | Koenraad F van der Sluijs, Dr. | Academic Medical Center, Amsterdam |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Marcus J. Schultz, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01773083 History of Changes |
| Other Study ID Numbers: | METC 2012_259, 2012-003289-42 |
| Study First Received: | January 16, 2013 |
| Last Updated: | January 18, 2013 |
| Health Authority: | the Netherlands: Central Committee on Research inv. Human Subjects (CCMO) the Netherlands: Institutional Review Board Amsterdam Belgium: Federal Agency for medicines and health products (FAGG) Belgium: Institutional Review Board (Leuven, Ghent, Antwerp; status: to be requested) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
Inhalation trauma pulmonary coagulopathy heparin nebulization mechanical ventilation |
Additional relevant MeSH terms:
|
Calcium heparin Heparin Respiratory Aspiration Burns Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Wounds and Injuries |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013