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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002316-12
    Sponsor's Protocol Code Number:SR052012
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-23
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-002316-12
    A.3Full title of the trial
    The safety and feasibility of administering xenon to patients undergoing off-pump coronary artery bypass graft surgery: a pilot study

    XOPCAB – Xenon in Off-Pump Coronary Artery Bypass Grafting
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The safety and feasibility of administering Xenon-gas (anesthesia) to patients who are undergoing an off-pump (heart keeps beating on its own) bypass of the coronary artery

    XOPCAB stands for: Xenon in Off-Pump Coronary Artery Bypass Grafting
    A.3.2Name or abbreviated title of the trial where available
    XOPCAB – Xenon in Off-Pump Coronary Artery Bypass Grafting
    A.4.1Sponsor's protocol code numberSR052012
    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 SponsorUniversity Hospitals of the KU Leuven
    B.1.3.4CountryBelgium
    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 supportUniversity Hospitals Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospitals of the KU Leuven
    B.5.2Functional name of contact pointAnesthesia Research
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003216344620
    B.5.5Fax number003216344245
    B.5.6E-mailchristel.huygens@uzleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Xenon
    D.2.1.1.2Name of the Marketing Authorisation holderAir Liquide
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Inhalation gas
    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 INNXENON (133XE)
    D.3.9.1CAS number 14932-42-4
    D.3.9.4EV Substance CodeSUB00104MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 sevorane
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Inhalation gas
    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 INNsevoflurane
    D.3.9.1CAS number 28523-86-6
    D.3.9.3Other descriptive nameSEVOFLURANE
    D.3.9.4EV Substance CodeSUB10506MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Xenon anesthesia in cardiac surgery
    E.1.1.1Medical condition in easily understood language
    Xenon anesthesia in cardiac surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    The aim of this study is to assess whether opioid-based xenon-anaesthesia,as compared to opioid-based sevoflurane anaesthesia, can be safely administered to patients undergoing off-pump coronary artery bypass surgery.
    E.2.2Secondary objectives of the trial
    Evaluation of:

    - MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions; postoperative coronary.

    - Any cerebrovascular accident not included in MACCE

    - Any complication occurring in the early postoperative period and not mentioned above (i.e. wound infection, bleeding)

    - Duration of postoperative intensive care unit and hospital stay

    - Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)

    - Occurrence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM or CAM-ICU for patients in ICU), to be assessed in combination with the Mini-Mental State Examination (MMSE)

    - Incidence of further AE, SAE and SUSAR not included above
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with coronary artery disease scheduled for elective OPCAB-surgery

    - Patients willing and able to complete the requirements of this study

    - Ejection Fraction > 30%
    E.4Principal exclusion criteria
    - Lack of informed consent
    - Age < 18 years
    - Pregnancy
    - COPD GOLD > II
    - Renal dysfunction defined as serum-creatinine > 1.5 mg/dl
    - Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
    - Single vessel grafting
    - Disabling neuropsychiatric disorders (severe dementia, Alzheimer’s disease, schizophrenia, depression), history of stroke with residuals, increased intracranial pressure
    - Hypersensitivity to the study medication
    - Presumed uncooperativeness or legal incapacity
    E.5 End points
    E.5.1Primary end point(s)
    The feasibility and safety of xenon application compared to sevoflurane application after coronary artery bypass graft surgery, as assessed by Depth of anaesthesia, Arterial and peripheral oxygen saturation, Perianaesthetic haemodynamic profile, Renal function and Requirement for blood (product) transfusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after discharge from the hospital.
    E.5.2Secondary end point(s)
    - MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions; postoperative coronary.

    - Any cerebrovascular accident not included in MACCE

    - Any complication occurring in the early postoperative period and not mentioned above (i.e. wound infection, bleeding)

    - Duration of postoperative intensive care unit and hospital stay

    - Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)

    - Occurrence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM or CAM-ICU for patients in ICU), to be assessed in combination with the Mini-Mental State Examination (MMSE)

    - Incidence of further AE, SAE and SUSAR not included above
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after discharge from the hospital.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    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 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
    Last visit, last subject i.e. 6 months after last patient's discharge.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned 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: 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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Not different from usual care
    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 Decision2012-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-14
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