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    The EU Clinical Trials Register currently displays   36775   clinical trials with a EudraCT protocol, of which   6073   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-001863-35
    Sponsor's Protocol Code Number:THAM
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-28
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-001863-35
    A.3Full title of the trial
    Effects of Tromethamine on Cerebral Oxygenation and Metabolism in Patients Suffering Intractable Intracranial Hypertension – an exploratory study.
    Der Effekt von Tromethamine auf die zerebrale Oxygenierung und Metabolismus in der Behandlung von kritisch erhöhtem Hirndruck – eine explorative Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Tromethamine on Brain Oxygenation and Metabolism in Patients Suffering Intractable Intracranial Hypertension – an exploratory study.
    Der Effekt von Tromethamine auf die Oxygenierung des Gehirns und den Gehirnstoffwechsel in der Behandlung von kritisch erhöhtem Hirndruck – eine explorative Studie
    A.3.2Name or abbreviated title of the trial where available
    Effect of Tromethamine on Cerebral Oxygenation
    Der Effekt von Tromethamine auf die zerebrale Oxygenierung
    A.4.1Sponsor's protocol code numberTHAM
    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 SponsorUniversitätsklinik für Klinische Pharmakologie, Medizinische Universität Wien
    B.1.3.4CountryAustria
    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 supportMedical University Vienna, Department of Clinical Pharmacology
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Vienna, Department of Clinical Pharmacology
    B.5.2Functional name of contact pointSecretary
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004314040029810
    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 Tris 36,34% Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen Aktiengesellschaft
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTris 36,34% Braun
    D.3.2Product code 6723632.00.00
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTROMETAMOL
    D.3.9.1CAS number 77-86-1
    D.3.9.4EV Substance CodeSUB11336MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critically ill patients (SAH, ICB, AVM bleedings, malignant MCA infarcts) under sedation and mechanical ventilation in need of multimodality monitoring, including brain tissue oxygen monitoring and microdialysis. In this population, elevated intracranial pressure (ICP) remains a major complication. As salvage therapy of intractable intracranial hypertension Tromethamine is often administered in an off-label indication for lowering ICP.
    E.1.1.1Medical condition in easily understood language
    Life-threatening intracranial hypertension in patients with severe neurological disease, e.g. intracranial bleeding
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    We propose to investigate effects of tromethamine on ICP and regional brain tissue oxygen tension (ptiO2) as measured by Neurovent PTO microprobes in critically ill patients under sedation and mechanical ventilation at a neurosurgical ICU suffering with acute intractable ICP elevation.
    E.2.2Secondary objectives of the trial
    effects of tromethamine 10, 30 and 60 minutes after first bolus administration on:
    intracranial pressure
    mean arterial pressure
    cerebral perfusion pressure
    cerebral metabolism measured by cerebral microdialysis (glucose, lactate, pyruvate, glycerol, and glutamate)
    TCD flow velocities
    arterial blood gas values (pH, pCO2, pO2, bicarbonate, base excess)

    dosage and frequency of tromethamine administration
    concomitant medication for ICP control
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age > 18 years
    - patient is in need of multimodality monitoring, including ICP, regional brain tissue oxygen tension (ptiO2) measurement and microdialysis
    - Clinical indication for THAM administration for treatment of intractable intracranial hypertension (ICP > 20mmHg)
    E.4Principal exclusion criteria
    - Patient age < 18 years
    - blood pH > 7,5
    - no need of multimodality monitoring
    - mannitol administration within the last 3 hours (half-life time of 100min)
    - immediate need for concomitant administration of mannitol
    E.5 End points
    E.5.1Primary end point(s)
    ptiO2 10, 30 and 60 minutes after tromethamine administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    10, 30 and 60 minutes after tromethamine administration
    E.5.2Secondary end point(s)
    intracranial pressure
    mean arterial pressure
    cerebral perfusion pressure
    cerebral metabolism measured by cerebral microdialysis (glucose, lactate, pyruvate, glycerol, and glutamate)
    TCD flow velocities
    arterial blood gas values (pH, pCO2, pO2, bicarbonate, base excess)
    E.5.2.1Timepoint(s) of evaluation of this end point
    10, 30 and 60 minutes after tromethamine administration
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    exploratory pharmacodynamic open label single arm study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    The trial will be terminated prematurely in any of the following cases
    for example:
    • Slow recruitment
    • Poor quality of data
    • Status of drug development changes
    • Attempted or proven fraud
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-06-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In view of the life-threating nature of the underlying disease, patients under sedation and mechanical ventilation are per definition incapable of giving consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 Decision2016-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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