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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-003289-42
    Sponsor's Protocol Code Number:41399
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-003289-42
    A.3Full title of the trial
    Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effectiveness and safety of heparin inhalation to treat lung coagulation disturbances in burn patients with inhalation trauma.
    A.3.2Name or abbreviated title of the trial where available
    Hepburn study
    A.4.1Sponsor's protocol code number41399
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAcademic Medical Center Amsterdam
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDutch Burns Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center Amsterdam
    B.5.2Functional name of contact pointGlas G.J.
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205668222
    B.5.5Fax number0031205669111
    B.5.6E-mailg.j.glas@amc.uva.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name unfractionated heparin sodium
    D.2.1.1.2Name of the Marketing Authorisation holderAny approved commercial source
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameunfractionated heparin sodium
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNunfractionated heparin sodium
    D.3.9.1CAS number 9005-49-6
    D.3.9.2Current sponsor codeCAS nr 9005-49-6
    D.3.9.3Other descriptive nameHEPARIN
    D.3.9.4EV Substance CodeSUB02475MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Burn-associated inhalation trauma requiring intubation and mechanical ventilation.
    E.1.1.1Medical condition in easily understood language
    Inhalation trauma (burn associated respiratory tract injury) in burn patients who need mechanical ventilation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of nebulized heparin on duration of mechanical ventilation in burn patients with confirmed inhalation trauma.
    E.2.2Secondary objectives of the trial
    • To determine the effect of nebulized heparin on relevant and frequently–used outcome parameters.
    • To determine the effect of nebulized heparin on pulmonary coagulation and fibrinolysis, and pulmonary inflammation.
    • To determine safety of nebulized heparin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - informed consent
    - age > 18 years
    - need for invasive mechanical ventilation
    - clinical diagnosis of inhalation trauma: initially on basis of indirect observations, followed by confirmation through bronchoscopy
    E.4Principal 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)
    E.5 End points
    E.5.1Primary end point(s)
    Number of ventilator-free days during the first 28 days after inclusion
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily.
    Moment of successful detubation (at least 24 hours free of mechanical ventilation) in a 28-day periode
    E.5.2Secondary end point(s)
    - clinical parameters such as Lung Injury Score (LIS), ICU length-of-stay (LOS), 28- and 90-day mortality, sedation, number of bronchoscopies performed to remove foreign particles and accumulated secretions , incidence of pneumonia.

    - pulmonary coagulation and fibrinolysis in burn patients with inhalation trauma as reflected by tissue factor, activated factor VII, antithrombin, thrombin-antithrombin complexes and activated protein C, plasminogen activator activity, tissue plasminogen activator, urokinase plasminogen activator and plasminogen activator inhibitor 1, and FDP in BALF.

    - pulmonary inflammation in burn patients with inhalation trauma as reflected by IL–1 beta, IL–6, IL-8, IL-10, TNF-alpha, VEGF and TGF-beta.

    - Occurence and severety of bleeding events
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Clinical parameters: daily routine clinical data collection
    - pulmonary coagulation, fibrinolysis and inflammation: blood and BAL sampling will be performed every other day
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as moment of discharge of the last included patient (n=118).

    Stopping guidelines for safety will be left at discretion of de Data Safety Monitoring Board
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients are intubated and mechanically ventilated. As a consequence, many of them are sedated and therefore incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 118
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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