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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2015-003650-40
    Sponsor's Protocol Code Number:DEPTHip2016
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-19
    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 number2015-003650-40
    A.3Full title of the trial
    Delirium in Elderly Patients with Trauma of the Hip
    Delier bij oudere patienten met een trauma van de heup
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acute confusional state in elderly patients with a broken hip
    Acute staat van verwardheid bij oudere patienten met een gebroken heup
    A.3.2Name or abbreviated title of the trial where available
    DEPTHip Study
    DEPTHip Studie
    A.4.1Sponsor's protocol code numberDEPTHip2016
    A.5.4Other Identifiers
    Name:NL54580.018.15Number:ABR Number
    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 SponsorAmsterdam UMC, locatie AMC
    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 supportZonMW
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAcademic Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, locatie AMC
    B.5.2Functional name of contact pointM.L. Ridderikhof
    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 number00310205660973
    B.5.5Fax number00310205669191
    B.5.6E-mailm.l.ridderikhof@amsterdamumc.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 Bupivacaine Hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC
    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 nameBupivacaine Hydrochloride
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    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
    hip fracture
    heupfractuur
    E.1.1.1Medical condition in easily understood language
    broken hip
    gebroken heup
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10053220
    E.1.2Term Hip injury
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033432
    E.1.2Term Pain in hip
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether the use of a continuous ultrasound-guided Fascia Iliaca Compartment Block employing catheter technique, administered in the ED within 2 hours after presentation of an elderly patient with a hip fracture, can decrease the incidence of delirium during the clinical course (hospital admission) and the first three months after discharge from the hospital.
    Onderzoeken of het gebruik van een continu, echogeleid fascia iliaca compartiment blok met achterlating van een catheter, ingebracht op de SEH binnen 2 uur na binnenkomst na presentatie van een oudere patient met een heupfractuur, de incidentie van delier tijdens het klinische beloop en de 1e drie maanden na ontslag uit het ziekenhuis kan verminderen.
    E.2.2Secondary objectives of the trial
    To investigate effectiveness in pain treatment, satisfaction of patients and staff, functional evaluation and an economic evaluation.
    Onderzoeken van effectiviteit in pijnbestrijding, tevredenheid patienten en staf, functionele evaluatie en economische evaluatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age 55 years and older
    - hip fracture
    - leeftijd 55 jaar en ouder
    - heupfractuur
    E.4Principal exclusion criteria
    - multiple injuries (polytrauma patients)
    - previous adverse reaction or known allergy to local anaesthetics or opioids or paracetamol
    - delirious at presentation in the ED
    - multitrauma patient (meerdere letsels)
    - eerdere overgevoeligheidsreactie of allergie op lokaal anesthetica of andere pijnstillers
    - delirant op moment van presentatie op SEH
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the occurrence of delirium during the entire hospital stay, until three months after discharge from the hospital.
    Het primaire eindpunt is het optreden van delier tijdens de gehele ziekenhuisopname, tot 3 maanden na ontslag uit het ziekenhuis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1 in the ED: Delirium is assessed using the Confusion Assessment Method (exclusion criterium)
    Phase 2 in the hospital: Delirium is continuously screened during hospital stay by using Delirium Observation Screening Scale (DOSS) during each nursing shift and the CAM and CAM-ICU in surgery, recovery and ICU.
    Phase 3 after discharge: Delirium is assessed at 1 and 3 months after discharge
    Fase 1 op de SEH: Screening voor delier met de Confusion Assessment Method (CAM); exclusiecriterium
    Fase 2 in het ziekenhuis: Screening vindt continu plaats gedurende de opname middels de DOSS schaal gedurende elke verpleegkundige dienst en de CAM en CAM-ICU in de peri-operatieve setting en de ICU
    Fase 3 na ontslag: delier wordt vastgesteld op 1 en 3 maanden na ontslag
    E.5.2Secondary end point(s)
    - Duration (defined as the total number of days with delirium) and the severity (percentage of patients with duration > 2 days) of delirium;
    - Pain (NRS pain scores during complete hospital stay, as well as need for rescue analgesia);
    - Satisfaction of patients and health care staff regarding efficacy of pain treatment and method of pain treatment in the ED and daily during hospital admission (5-point Likert scales and reference questions);
    - Hospital stay characteristics (length of stay, ICU admission and ICU length of stay, hospital re-admission rate, occurrence of complications of hip surgery and medical complications, all cause in-hospital-mortality and mortality after hospital discharge);
    - Functional status:
    - (15-item modified Katz Index of Activities of Daily Living) based on 2 weeks before presentation and after 3 months;
    - The Oxford Hip Score after 3 months;
    - Generic HRQol (Euroqol - EQ-5D-5L) at 3 months;
    - Cognitive function (Mini Mental State Examination at inclusion, at discharge and at 3 months;
    - Economic evaluation (cost-effectiveness and cost-utility analysis), QALY's calculated by product sum of utility of each health state (EQ-5D-5L) and times in between observations, direct and indirect medical and non-medical costs, health-related costs of patients and family;
    Baseline parameters are: time of presentation at Emergency Department and time to application of the intervention or administration of analgesics, age, sex, medical history and medication use, type of hip fracture (medial or lateral collum fracture, per- or inter-trochanteric).
    - Duur en ernst van delier
    - Pijn (NRS pijnscores en noodzaak tot additionele pijnmedicatie)
    - Tevredenheid patienten en staf aangaande effectiviteit pijnbestrijding en methode van pijnbestrijding op de SEH en gedurende het ziekenhuisverblijf (5-punt Likert schalen en referentievragen)
    - Karakteristieken ziekenhuisopname (duur, IC opname en -duur, heropname, complicaties, mortaliteit)
    - Functionele status:
    - (15-item gemodificeerde Katz Index van Activititeiten van het Dagelijks Leven) gebaseerd op 2 weken voor presentatie en 3 maanden na
    ontslag;
    - De Oxford Hip Score na 3 maanden;
    - Generieke HRQol (Euroqol - EQ-5D-5L) na 3 maanden;
    - Cognitieve functie (Mini Mental State Examination bij inclusie, ontslag en na 3 maanden;
    - Economische evaluatie (kosteneffectiviteit en kosten-utiliteit)
    - Baseline parameters: leeftijd, sekse, voorgeschiedenis en medicatiegebruik, tijden van presentatie tot behandeling met pijnmedicatie of interventie, type fractuur.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1 in the ED: baseline characteristics are documented, as well as baseline pain scores and initial pain scores after the initiation of pain treatment
    Phase 2 in hospital: pain is assessed continuously during each nursing shift; all characteristics can partly be obtained pro- and retrospectively
    Phase 3 after discharge: At 1 and 3 months the health questionnaires are recorded
    Fase 1 op de SEH: baseline karakteristieken worden gedocumenteerd, net als eerste pijnscores voor en na de interventie of de vergelijkende pijnbestrijdingsmethode
    Fase 2 in het ziekenhuis: pijn wordt continu vastgesteld tijdens elke verpleegkundige dienst, alle karakteristieken van ziekenhuisopname kunnen deeld prospectief en deels retrospectief worden gedocumenteerd
    Fase 3 na ontslag: 1 en 3 maanden na ontslag worden de gezondheidsvragenlijsten ingevuld
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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) 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 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 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
    Gewoonlijke zorg volgens standaard lokaal protocol / nationale richtlijn
    Usual care according to local protocol
    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 concerned4
    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
    End of trial will be when 340 patients are included in total, divided over 2 treatment arms, last included patients is completely followed-up (3 months after discharge from hospital).

    Justification of earlier end of trial will be on discretion of the study group, as all possible catheter related complications will be investigated thoroughly.
    Einde van de studie is wanneer alle 340 patienten, verdeeld over de 2 armen, zijn geincludeerd en volledige follow-up van de laatste patient is voltooid (3 maanden na ontslag uit het ziekenhuis).

    Eventuele eerdere beeindiging van de studie zal zijn naar discretie van de studiegroep en alle mogelijke catheter gerelateerde complicaties zullen grondig worden geevalueerd binnen de groep.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with dementia
    Patienten met dementie
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state340
    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
    Geen
    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 Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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