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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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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    EudraCT Number:2017-001300-30
    Sponsor's Protocol Code Number:2017_CERVPLEX_1.1
    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:2017-08-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-001300-30
    A.3Full title of the trial
    Comparison of deep, intermediate and superficial cervical plexus block for carotid endarterectomies concerning paresis of the phrenic nerve, lung function and tissue distribution: a prospective, randomised-controlled, observerblinded study
    Vergleich der tiefen, mittleren und oberflächlichen zervikalen Plexusblockade zur Karotisendarteriektomie hinsichtlich Parese des Nervus Phrenicus, Lungenfunktion und Gewebeverteilung: Eine prospektive, randomisiert-kontrollierte, verblindete Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of deep, intermediate and superficial regional anesthetic block for carotid surgery concerning nerval paresis, lung function and tissue distribution
    Vergleich der tiefen, mittleren und oberflächlichen Regionalanästhesie zur Karotischirurgie hinsichtlich Nervenlähmung, Lungenfunktion und Gewebeverteilung
    A.3.2Name or abbreviated title of the trial where available
    Cervical plexus anesthesia study
    Zervikale Plexus Anästhesie Studie
    A.4.1Sponsor's protocol code number2017_CERVPLEX_1.1
    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 SponsorUK für Anästhesieologie, Gemeinn. Sbg. Landeskliniken BetriebsgesmbH
    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 supportUK für Anästhesieologie, Gemeinn. Sbg. Landeskliniken BetriebsgesmbH
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUK für Anästhesieologie, Gemeinn. Sbg. Landeskliniken BetriebsgesmbH
    B.5.2Functional name of contact pointDepartment office
    B.5.3 Address:
    B.5.3.1Street AddressMüllnerhauptstraße 48
    B.5.3.2Town/ citySalzburg
    B.5.3.3Post code5020
    B.5.4Telephone number00435725524004
    B.5.5Fax number00435725524199
    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. name Dotarem
    D. of the Marketing Authorisation holderGuerbet
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameDotarem
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgadoterate meglumine
    D.3.9.1CAS number 72573-82-1
    D.3.9.4EV Substance CodeSUB02297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number279.32
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    deep, intermediate or superficial cervical plexus block for carotid endarterectomy
    tiefer, mittlerer oder oberflächlicher zervikaler Plexusblock für Karotisendarterektomie
    E.1.1.1Medical condition in easily understood language
    regional anesthesia technique for carotid surgery
    regionalanästhesiologische Technik für Karotischirurgie
    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
    to study the difference of extend or incidence of phrenic nerve paralysis measured by diaphragmatic motion after deep, intermediate or superficial cervical plexus blockade
    den Unterschied in Ausmaß und Inzidienz einer Parese des Nervus phrenicus gemessen an der Zwerchfellbeweglichkeit nach tiefer, mittlerer oder oberflächlicher cervikalen Plexusblockade
    E.2.2Secondary objectives of the trial
    to measure lung function and tissue distribution of the regional anesthetic injection after deep, intermediate or superficial cervical plexus blockade
    Lungenfunktionsmessungen und Gewebeverteilung der regionalanästhesiologischen Injektion nach tiefer, mittlerer oder oberflächlicher cervikalen Plexusblockade
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patient for planned, elective endarterectomies for symptomatic or asymptomatic stenosis of the carotid artery
    - planned surgery under regional anesthesia
    - consent to the study protocol after extensive information
    - Patienten vor elektiv geplanter Endarteriektomie bei symptomatischer oder asymptomatischer Stenose der A. carotis
    - Geplanter Eingriff in Regionalanästhesie
    - Einwilligung in die Studienteilnahme nach ausführlicher Aufklärung
    E.4Principal exclusion criteria
    - age under 18 years, patients unable to consent
    - pregnancy, lactation period
    - contraindications for MRI study and/or contrast agent
    - implants or incorporated material, e.g. cardiac pacemakers, prohibiting MRI study
    - claustrophobia
    - inability to remain inside of MRI due to physical restriction
    - kidney impairement (GFR <30ml/min)
    - liver failure (>Child A)
    - contraindications to regional anesthesia and/or study medication
    - severe lungdysfunction
    - language or communications barrier prohibiting surgery under regional anesthesia
    - Alter < 18 Jahre, beziehungsweise nicht einwilligungsfähige Patienten
    - Schwangerschaft/Stillzeit
    - Kontraindikationen gegen MR-Untersuchungen und/oder Kontrastmittel
    - Nicht MRT-taugliche inkorporierte Fremdmaterialien, insbesondere Herzschrittmacher
    - Klaustrophobie
    - Auf Grund einer körperlichen Einschränkung vorhersehbares Lagerungsproblem im MRT
    - Nierenfunktionseinschränkungen (GFR <30ml/min)
    - Leberversagen (> Child A)
    - Kontraindikation gegen Regionalanästhesie und/oder gegen die Studienmedikation
    - Einschluss in andere, das vorliegende Studienprotokoll beeinflussende Studien
    - Schwere Lungenfunktionsstörungen
    - Sprach oder Kommunikationsbarrieren welche eine ausreichende Kooperation in Regionalanästhesie verhindern
    E.5 End points
    E.5.1Primary end point(s)
    difference in the change in diaphragmatic motion (in cm) before and after deep, intermediate or superficial cervical plexus blockade
    Unterschied in der Veränderung der Zwerchfellbewegung (in cm) vor und nach tiefer, mittlerer oder cervikaler Plexusblockade
    E.5.1.1Timepoint(s) of evaluation of this end point
    before and after cervical plexusblockade
    vor und nach der Blockade
    E.5.2Secondary end point(s)
    - lung function tests (FEV1, FVC) before and after blockade
    - tissue distribution of local anesthetic solutaion and anatomical distance to nerval structures in the MRI
    - incidence of epidureal spread
    - mean Sp02 and paO2 measurements before and after blockade
    - supplementary oxygen before, during and after surgery
    - incidence of clinically relevant tachycardia, hypo/hypertension
    - incidence of conversion to general anesthesia
    - incidence of side effects of regional anesthesia (Horner's, Dysphagia, hoarseness, palsy of the facial or recurrent nerve)
    - amount of supplimental analgesia by fentanyl
    - amount of supplimental lokalanesthetic by surgeon
    - postoperative pain scores
    - surgery duration and clamping duration of the carotid artery
    - cerebral oxygenation
    - incidence and extent of temporary neurological symptoms
    - incidence of carotid shunting by surgeon
    - incidence of cardiovascular complications (cerebral ischemia, ACS)
    - patient satisfaction
    - Lungenfunktionstests (FEV1, FVC) vor und nach Blockade
    - Ausbreitung und anatomische Nähe zu nervalen Strukturen im MRT
    - Inzidenz von epiduraler Ausbreitung des Lokalanästhetikums
    - Durchschnittliche SpO2 und pa02 Messungen vor und nach Blockade
    - Supplementäre Sauerstoffgabe vor, während und nach dem Eingriff
    - Inzidenz von klinisch relevanter Tachykardie, Hypo/Hypertonie
    - Inzidenz der Notwendigkeit zur Allgemeinanästhesie zu wechseln
    - Inzidenz an klinischen Nebenwirkungen in direkten Zusammenhang mit der Regionalanästhesie (Horner Syndrom, Schluckstörungen, Heiserkeit, Fazialisparsese, Recurrensparese)
    - Menge an zusätzlicher Analgesie/Sedierung mit Fentanyl
    - Menge an zusätzlicher Lokalanästhetikagabe durch den Operateur
    - Postoperative Schmerzscores
    - Operationsdauer und Klemmzeiten der A. carotis
    - Zerebrale Sauerstoffsättigung
    - Inzidenz und Ausmaß temporärer neurologischer Phänomene
    - Inzidenz der Notwendigkeit eines Karotisshunts
    - Inzidenz an kardiovaskulären Ereignissen (Insult, transitorische ischämische Attacke und akutes Koronarsyndrom)
    - Patientenzufriedenheit, dokumentiert mittels des modifizierten abteilungsinternen Standards zur Erhebung der Patientenzufriedenheit
    E.5.2.1Timepoint(s) of evaluation of this end point
    as listed above, before and after block, or before, during and after surgery until discharge from monitoring ward
    wie oben genannt, vor und nach Blockade, bzw. vor, während und nach dem Eingriff bis zur Entlassung von der Überwachungsstation
    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 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. 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    kontrolliert entsprechend regional anesthestiologischer Technik
    controlled for regional anesthetic technique
    E.8.2.4Number of treatment arms in the trial3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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.1.3Elderly (>=65 years) Yes
    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 2017-08-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state45
    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)
    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 Decision2017-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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