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Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma (Hepburn)

This study has been terminated.
(insufficient recruitment of patients and high costs associated with the purchase and blinding of study medication)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773083
First Posted: January 23, 2013
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dutch Burns Foundation
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Number of ventilator-free days at day 28 [ Time Frame: at day 28 ]
    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 ]
    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 ]
    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 ]
    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)


Enrollment: 13
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: October 2016 (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:
  • unfractionated heparin sodium, EV Product Code: SUB02475MIG,
  • Marketing Authorisation number: RVG 01372
  • ATC codes: B01AB01
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773083


Locations
Australia, Victoria
St Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Belgium
University Hospital, Gent
Gent, Oost-Vlaanderen, Belgium, 9000
University Hospital Gasthuisberg - Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Ziekenhuis Netwerk Antwerpen- Stuivenberg
Antwerpen, Belgium, 2000
Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Red Cross Hospital, Beverwijk, the Netherlands
Beverwijk, Noord-Holland, Netherlands, 1942 LE
Maasstad Hospital
Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
Martini Hospital
Groningen, Netherlands, 9728 NT
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Burns Foundation
Investigators
Principal Investigator: Marcus J Schultz, MD-PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: HepBurn
2012-003289-42 ( EudraCT Number )
First Submitted: January 16, 2013
First Posted: January 23, 2013
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Inhalation trauma
pulmonary coagulopathy
heparin nebulization
mechanical ventilation

Additional relevant MeSH terms:
Wounds and Injuries
Respiratory Aspiration
Burns
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action