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    Summary
    EudraCT Number:2015-003498-13
    Sponsor's Protocol Code Number:HIP/FUSION#1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-01-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-003498-13
    A.3Full title of the trial
    Surgical anesthesia for elective hip surgery - hemodynamic effect of lumbosacral plexus blockade compared to continuous spinal anesthesia
    Kirurgisk anæstesi til elektiv hoftekirurgi – hæmodynamisk påvirkning ved ultralydsvejledt lumbosacral plexusblokade sammenlignet med titreret spinalanæstesi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anesthesia for planned hip surgery - comparison of the effect on heart and blood circulation from peripheral nerve blockade and spinal anesthesia
    Bedøvelse til planlagt hoftekirurgi - sammenligning af påvirkningen på hjerte og blodkredsløb ved perifer nerveblokade og rygmarvsbedøvelse
    A.4.1Sponsor's protocol code numberHIP/FUSION#1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02544269
    A.5.4Other Identifiers
    Name:Local health research ethics committee no.Number:51392
    Name:Danish data protection agency no.Number:2015-57-0002
    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 SponsorInstitut for Klinisk Medicin, Aarhus Universitet
    B.1.3.4CountryDenmark
    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 supportA.P. Møller og Hustru Chastine Mc-Kinney Møllers Fond til almene Formaal
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportKong Christian den Tiendes Fond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportGraduate School of Health, Aarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut for Klinisk Medicin, Aarhus Universitet
    B.5.2Functional name of contact pointNiels Dalsgaard Nielsen
    B.5.3 Address:
    B.5.3.1Street AddressNoerrebrogade 44, building 1C, 1st floor
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+452283 8334
    B.5.6E-mailnielsdn@dadlnet.dk
    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 Marcain Spinal
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaine
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Ropivacain "Fresenius Kabi"
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 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 INNRopivacaine
    D.3.9.3Other descriptive nameROPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboPerineural use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntrathecal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    No specific medical condition is investigated. The objective of the investigation is to compare two methods for surgical anesthesia for total hip replacement.
    Der undersøges ikke en specifik medicinsk tilstand. Studiets formål er at sammenligne to metoder til kirurgisk anæstesi til hoftealloplastik.
    E.1.1.1Medical condition in easily understood language
    No specific medical condition is investigated. The objective of the investigation is to compare two methods for anesthesia for major hip surgery.
    Der undersøges ikke en bestemt sygdom eller tilstand. Studiets formål er at sammenligne to metoder til bedøvelse til operation med stor hoftekirurgi.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10068084
    E.1.2Term Anesthesia procedure
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the hemodynamic effect of lumbosacral plexus blockade versus continuous spinal anesthesia.
    Sammenligning af den hæmodynamiske effekt af lumbosakral plexusblokade og kontinuerlig spinalanæstesi.
    E.2.2Secondary objectives of the trial
    Comparison of time for anesthesia performance, succes rate for surgical anesthesia, plasma concentrations of ropivacaine and lactate following anesthesia induction, cumulated dose of sedative administrated during surgery, cumulated dose of opioid after surgery, surgeons satisfaction with anesthesia and patients worst pain during surgery.
    Sammenigning af tid for blokadeanlæggelse, succes rate for kirurgisk anæstesi, plasmakoncentration af ropivacain og laktat efter induktion af anæstesi, kumuleret peroperativ dosis af sedativa, kumuleret postoperativ dosis af opioider, kirurgens tilfredshed med anæstesien, patientens værste smerter under operationen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients for total hip replacement under spinal anesthesia at Silkeborg Regional Hospital, Denmark
    Age ≥ 50 years
    American Society of Anesthesiologists physical status classification score I-III
    Informed consent
    Patienter indstillet til hoftealloplastik i spinalanæstesi på Regionshospitalet Silkeborg
    Alder ≥ 50 år
    American Society of Anesthesiologists physical status classification score I-III
    Informeret samtykke
    E.4Principal exclusion criteria
    Lack of ability to cooperate
    Lack of ability to speak Danish
    Cronic opioid demanding pain not originating from the hip area
    Previous major back surgery
    Previous venous tromboembolic event
    Severe cardiopulmonary dissease (NYHA class 4)
    Severe untreated hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 110 mm Hg)
    Obesity (BMI > 35 kg/m^2)
    Active treatment with amiodarone
    Active treatment with verapamil
    Allergy towards at least one IMP
    Manglende evne til korporation
    Manglende danskegenskaber
    Kroniske opioidkrævende smerter, der ikke stammer fra hofteregionen
    Tidligere venøs tromboemboli
    Tidligere større lumbal rygkirurgi
    Svær kardiopulmonal sygdom sv.t. NYHA IV
    Svær ubehandlet hypertension (Systolisk blodtryk > 160 mmHg eller diastolisk blodtryk > 110 mmHg)
    Fedme (BMI > 35 kg/m^2)
    Aktuel behandling med amiodaron
    Aktuel behandling med verapamil
    Overfølsomhed overfor de anvendte præparater
    E.5 End points
    E.5.1Primary end point(s)
    Significant reduction in anesthesia impact on cardiac output.
    Signifikant reduktion i anæstesiens påvirkning af cardiac output.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 5th minute after nerve blockade performance for 60 minutes.
    Hvert 5. minut efter anlæggelse af nerveblokader i 60 minutter.
    E.5.2Secondary end point(s)
    Time for nerve blockade performance
    Success rate of surgical anesthesia
    Change of cardiac stroke volume
    Change of systemic vascular resistance
    Change of mean arterial pressure
    Change of central venous oxygen saturation
    Maximum plasma ropivacaine concentration
    Change of plasma lactate concentration
    Cumulated peroperative dose of propofol
    Cumulated peroperative dose of opioids
    Cumulated postoperative dose of opioids
    Time from end of operation to first dose of opioid
    Surgeons satisfaction with anesthesia (numeric rating scale)
    Patients worst pain during surgery (numeric rating scale)
    Tid for blokadeanlæggelse
    Succesrate for blokadeanlæggelse
    Ændring af SV
    Ændring af SVR
    Ændring af MAP
    Ændring af SCVO2
    Maksimal værdi af plasma-ropivacain
    Ændring af plasma-laktat under observationsperioden
    Summeret peroperativ propofoldosis
    Postoperativt opioidbehov
    Tid fra operationens afslutning til første dosis dosis opioid
    Kirurgens tilfredshed med anæstesien (numerisk vurderingsskala)
    Patientens peroperative smertescore (numerisk vurderingsskala)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time for nerve blockade performance: Immediately after nerve blockade performance
    Success rate of surgical anesthesia: 40 minutes after nerve blockade performance
    Cardiovascular changes: Every 5th minute after nerve blockade performance for 60 minutes
    Plasma ropivacaine concentration: 20, 40, 60, 80, 100, 120, 140 and 160 minutes after nerve blockade performance
    Plasma lactate concentration: 0, 30 and 60 minutes after nerve blockade performance
    Peroperative propofol and opioid doses as well as surgeons satisfaction with anesthesia: As the patient leaves the operating room
    Patients pain during surgery: 1 hour after surgery
    Postoperative opioid dose and time-to-first opioid-dose: 24 hours after blockade performance
    Tid for blokadeanlæggelse: Umiddelbart efter anlæggelse af nerveblokader
    Succesrate for blokadeanlæggelse: 40 minuter efter anlæggelse af nerveblokader
    Kardiovaskulære ændringer: Hvert 5. minut efter anlæggelse af nerveblokader i 60 minutter.
    Plasma-ropivacain-koncentration: 20, 40, 60, 80, 100, 120, 140 og 160 min efter anlæggelse af nerveblokader
    Plasma-laktat-koncentratione: 0, 30 og 60 min efter anlæggelse af nerveblokader
    Peroperativ propofol- og opioiddosis såvel som kirurgens tilfredshed med anæstesien: Når patienten forlader operationsstuen
    Postoperativt opioidbehov og tid til første opioiddoses: 24 timer efter blokadeanlæggelse
    Patientens peroperative smerte: 1 time efter operationen
    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) 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) Yes
    E.8.2.2Placebo Yes
    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 of last patient.
    Efter besøg af sidste patient
    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 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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 2016-01-29. 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 state36
    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
    Comment regarding fields F.1.2.1 and F.1.3.1: The total number of subjects in this study is 36 persons on or above the age of 18. The correct value for each of the above mentioned fields should therefore be "0-36".
    Ingen
    Kommentar til felterne F.1.2.1 og F.1.3.1: The totale antal forsøgspersoner i studiet er 36 personer på eller over 18 år. Den korrekte værdi for de ovennævnte felter burde derfor være "0-36".
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Center for Planned Surgery, Silkeborg Regional Hospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-24
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