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    Summary
    EudraCT Number:2009-017153-35
    Sponsor's Protocol Code Number:ALMED-08-C2-020
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017153-35
    A.3Full title of the trial
    An international, multi-center, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.
    Eine internationale, multizentrische, randomisierte, kontrollierte Studie zur Untersuchung der Wirkung von Xenon auf postoperatives Delirium bei älteren Patienten, die einer Hüftfrakturoperation unterzogen werden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hip fracture surgery in elderly patients
    Hüftfrakturoperation bei älteren Patienten
    A.3.2Name or abbreviated title of the trial where available
    Hip fracture surgery in elderly patients
    HIPELD
    A.4.1Sponsor's protocol code numberALMED-08-C2-020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01199276
    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 SponsorAIR LIQUIDE SANTE INTERNATIONAL
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIR LIQUIDE SANTE INTERNATIONAL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAIR LIQUIDE SANTE INTERNATIONAL
    B.5.2Functional name of contact pointJoel GUITTET
    B.5.3 Address:
    B.5.3.1Street Address1, chemin de la porte des loges
    B.5.3.2Town/ cityjouy en josas
    B.5.3.3Post code78354
    B.5.3.4CountryFrance
    B.5.4Telephone number330139072068
    B.5.5Fax number330139076199
    B.5.6E-mailjoel.guittet@airliquide.com
    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 LENOXe
    D.2.1.1.2Name of the Marketing Authorisation holderAIR LIQUIDE Santé INTERNATIONAL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namexenon
    D.3.4Pharmaceutical form Inhalation vapour
    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
    D.3.9.1CAS number 7440-63-3
    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.2.1.2Country 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 namesevoflurane
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    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.3.9.2Current sponsor codesevoflurane
    D.3.9.3Other descriptive namesevoflurane
    D.3.9.4EV Substance Codesevoflurane
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 100
    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
    Post-operative delirium after hip fracture surgery under general anaesthesia
    Postoperatives Delirium nach einer Hüftfrakturoperation unter Vollnarkose
    E.1.1.1Medical condition in easily understood language
    Hip fracture surgery
    Hüftfrakturoperation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020100
    E.1.2Term Hip fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia, with xenon or sevoflurane, for a period of four days post-surgery.
    Primäre Zielsetzung:
    Beurteilung der Inzidenz von postoperativem Delirium (POD), diagnostiziert mit der Confusion Assessment Method (CAM), bei älteren Patienten, die einer Hüftfrakturoperation unter Vollnarkose mit Xenon oder Sevofluran unterzogen werden, für vier Tage nach der Operation
    E.2.2Secondary objectives of the trial
    1. To compare the incidence of POD between xenon group and sevoflurane group.
    2. To evaluate the incidence of POD from Day 5 post-surgery until discharge from hospital
    3. To determine the time to first POD diagnosis
    4. To evaluate the duration of POD
    5. To evaluate the evolution of the physiological status of the patients in the post-operative period
    6. To evaluate the recovery parameters
    7. To collect preliminary data to evaluate the economical impact of POD in the post-operative period
    8. To collect safety data

    Sekundäre Zielsetzungen:
    1-Vergleich der Inzidenz von POD zwischen Xenon und Sevofluran
    2-Beurteilung der Inzidenz von POD ab Tag 5 nach der Operation bis zur Krankenhausentlassung
    3-Bestimmung der Zeit bis zur ersten POD-Diagnose
    4-Beurteilung der Dauer des POD
    5-Beurteilung der Entwicklung des physiologischen Status der Patienten in der postoperativen Periode
    6-Beurteilung der Erholungsparameter
    7-Erfassung von vorläufigen Daten zur Beurteilung der ökonomischen Auswirkung von POD in der postoperativen Periode
    8-Erfassung von Sicherheitsdaten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Elderly patient (≥ 75 years).
    - Patients with planned hip fracture surgery within 48 hours after the hip fracture.
    - Patient willing and able to complete the requirements of this study including the signature of the written informed consent.
    Einschlusskriterien:
    - Ältere Patienten (≥ 75 Jahre)
    - Patienten mit geplanter Hüftfrakturoperation innerhalb von 48 Stunden nach der Hüftfraktur
    - Patienten, die willens und in der Lage sind, die Anforderungen dieser Studie zu erfüllen, einschließlich Unterzeichnung der schriftlichen Einwilligungserklärung
    E.4Principal exclusion criteria
    - Patient suffering of multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (ie fracture of the middle and distal femur).
    - Disabling neuropsychiatric disorders (severe dementia, Alzheimer’s disease, schizophrenia, depression).
    - Brain trauma within 12 months prior to selection, history of stroke with residuals.
    - Patient suffering from delirium (CAM diagnosis) at selection.
    - Patients who cannot complete the pre-operative mental tests of this current clinical trial
    - Patients with Mini-Mental State Examination (MMSE) score < 24 at selection.
    - Contra-indication (serious illness or medical conditions) for general anaesthesia .
    - Known allergy or hypersensitivity to any drugs administered during the current clinical trial.
    - Previous participation in this current clinical trial.
    - Participation in another clinical trial within 4 weeks prior to selection.
    - History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent.
    - Patient known to susceptible to malignant hyperthermia.
    - Patient with elevated intra-cranial pressure.
    - Patient with a risk of high oxygen demand.
    - Patient with recent or ongoing myocardial infarction / damage.
    - Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function.
    - Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy.
    Ausschlusskriterien:
    - Patienten, die unter multiplen Frakturen, proximalen Beckenfrakturen, pathologischen Frakturen, Femurfrakturen leiden (d. h. Frakturen des mittleren oder distalen Femurs)
    -Behindernde neuropsychiatrische Störungen (schwere Demenz, Alzheimer-Krankheit, Schizophrenie, Depression)
    -Hirntrauma innerhalb von 12 Monaten vor der Auswahl, Krankengeschichte eines Schlaganfalls mit Residualbehinderung
    - Zum Zeitpunkt der Auswahl an Delirium leidende Patienten (CAM-Diagnose)
    -Patienten, die die präoperativen geistigen Tests (CAM und/oder MMSE) dieser klinischen Studie nicht durchführen können
    -Patienten mit einem MMSE-Score (Mini-Mental State Examination) von < 24 zum Zeitpunkt der Auswahl
    -Patienten mit bekannter oder vermuteter malignen Hyperthermie
    -Patienten mit erhöhtem intra-cranialen Druck
    -Patienten mit Risiko für erhöhten Sauerstoffbedarf
    -Patienten mit frischem oder noch persistierenden Myokardinfarkt / Schäden
    -Patienten mit schwerer Herzinsuffizienz, oder Patienten mit schwerer systolischer Linksventrikel-Dysfunktion
    -Patienten mit bekannten schweren Lungen und/oder Atemwegserkrankungen, oder schwerer chronischer respiratorischer Insuffizienz, oder kontinuierlicher Sauerstofftherapie in häuslicher Pflege
    -Kontraindikationen (schwere Krankheit oder medizinischer Zustand) für eine Vollnarkose
    -Bekannte Allergie oder Überempfindlichkeit gegenüber den in dieser klinischen Studie verabreichten Medikamenten
    -Frühere Teilnahme an dieser klinischen Studie
    -Teilnahme an einer anderen klinischen Studie innerhalb von 4 Wochen vor dem Zeitpunkt der Auswahl
    -Vorgeschichte von Alkohol- oder Drogenmissbrauch oder psychiatrische Störungen, die das Verständnis der notwendigen Informationen beeinträchtigen oder den Patienten medizinisch und rechtlich für die Erteilung einer schriftlichen Einwilligungsklärung unfähig machen könnten
    E.5 End points
    E.5.1Primary end point(s)
    Post-operative Delirium, diagnosed with the CAM, at least once within four days post surgery.
    Primärer Zielpunkt (Wiederholung nach Bedarf)
    Postoperatives Delirium diagnostiziert mit CAM, mindestens einmal innerhalb der vier Tage nach der Operation


    E.5.1.1Timepoint(s) of evaluation of this end point
    2 times per days at least 4 days after surgery
    Zeitpunkt(e) der Evaluierung dieses Zielpunktes
    Zweimal pro Tag, mindestens vier Tage nach der Operation
    E.5.2Secondary end point(s)
    - POD diagnosed with the CAM from Day 5 post-surgery to discharge from hospital
    - SOFA from Day 1 to Day 4 post-surgery
    - Recovery parameters
    - Economic parameters
    - Safety: Adverse Events Serious Adverse Events, laboratory parameters
    Sekundärer Zielpunkt (Wiederholung nach Badarf)
    -POD, diagnostiziert mit CAM, ab Tag 5 nach der Operation bis zur Krankenhausentlassung
    -SOFA von Tag 1 bis Tag 4 nach der Operation
    - Erholungsparameter
    - Ökonomische Parameter
    - Sicherheit: Unerwünschte Ereignisse - Schwerwiegende unerwünschte Ereignisse, Laborparameter
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 times per days at least 4 days after surgery for CAM
    1 time per day at least 4 days after surgery for SOFA
    1 time during visit 1 for recovery parameters
    Zeitpunkt(e) der Evaluierung dieses Zielpunktes
    - CAM: 2 mal täglich, mindestens bis Tag 4 nach der Operation
    - SOFA: 1 mal täglich, mindestens bis Tag 4 nach der Operation
    - Erholungsparameter: 1 mal während Visite 1
    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 No
    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 Yes
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    PR 2
    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 EEA13
    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
    Letzter Besuch des letzten Patienten
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 256
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 256
    F.4.2.2In the whole clinical trial 256
    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
    Keine
    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 Decision2010-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-28
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