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    Summary
    EudraCT Number:2012-002944-25
    Sponsor's Protocol Code Number:EuroHyp-1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-16
    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 ConcernedFinland - Fimea
    A.2EudraCT number2012-002944-25
    A.3Full title of the trial
    EuroHYP-1: European multicentre, randomised, phase III clinical trial of therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
    Euro-HYP: Eurooppalainen prospektiivinen avoin satunnaistettu kliininen monikeskustutkimus (faasi III) terapeuttisen hypotermian tehosta ja turvallisuudesta aivoinfarktin hoidossa standardihoitoon verrattuna
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EuroHYP-1: European phase III clinical trial at multiple trial sites and with random allocation of patients to treatment groups. The trial compares whole body cooling plus best medical treatment to best medical treatment alone in patients with acute stroke.
    EuroHYP: Eurooppalainen faasi III kliininen tutkimus, jossa on useita keskuksia ja tutkittavat satunnaistetaan kahteen hoitoryhmään. Tutkimuksessa verrataan aivohalvauspotilailla koko kehon viilennyshoitoa ja lääkehoitoa pelkkään lääkehoitoon.
    A.3.2Name or abbreviated title of the trial where available
    EuroHYP-1
    EuroHYP-1
    A.4.1Sponsor's protocol code numberEuroHyp-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01833312
    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 Hospital Erlangen
    B.1.3.4CountryGermany
    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 supportEuropean Comission
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Erlangen
    B.5.2Functional name of contact pointUniversity Hospital Erlangen
    B.5.3 Address:
    B.5.3.1Street AddressSchwabachanlage 6
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.6E-mailstefan.schwab@uk-erlangen.de
    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.2.1.2Country 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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPETHIDINE HYDROCHLORIDE
    D.3.9.1CAS number 50-13-5
    D.3.9.3Other descriptive namePETHIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03726MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUSPIRONE HYDROCHLORIDE
    D.3.9.1CAS number 33386-08-2
    D.3.9.3Other descriptive nameBUSPIRONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00906MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 3
    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 Ondansetrone
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameOndansetron
    D.3.2Product code A04AA01
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeA04AA01
    D.3.9.3Other descriptive nameONDANSETRON HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03517MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 4
    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 Granisetron Fresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameGranisetron Fresenius Kabi
    D.3.2Product code A04AA02
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGRANISETRON HYDROCHLORIDE
    D.3.9.1CAS number 107007-99-8
    D.3.9.2Current sponsor codeA04AA02
    D.3.9.4EV Substance CodeSUB02405MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Acute ischaemic stroke
    Akuutti aivoinfarkti
    E.1.1.1Medical condition in easily understood language
    Acute ischaemic stroke
    Akuutti aivoinfarkti
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, improves functional outcome at 3 months in patients with acute ischaemic stroke.
    Selvittää parantaako 6 tunnin kuluessa aivoinfarktin oireista aloitettu ja 24 tuntia kestävä kehon lämpötilan alentaminen 34-35 C asteeseen aivoinfarktipotilaiden toipumista 3 kk kuluttua sairastumisesta.
    E.2.2Secondary objectives of the trial
     To assess the effect of systemic cooling to a target body temperature between 34.0 and 35.0°C, started within 6 hours of symptom onset and maintained for 24 hours, in patients with acute ischaemic stroke on
    • mortality at 3 months.
    • neurological outcome at 3 months.
    • quality of life at 3 months.
    • cerebral infarct size at 48±24 hours.
     To determine the safety and tolerability of systemic cooling in patients with acute ischaemic stroke.
    Selvittää hypotermiahoidon vaikutus aivoinfarktipotilaan
    -kuolleisuuteen 3 kk kuluessa
    -neurologiseen toipumiseen 3 kk kuluttua
    -elämänlaatuun 3 kk kuluttua
    -aivoinfarktin kokooon 1-3 vrk hoidon jälkeen
    Selvittää hypotermiahoidon turvallisuus ja siedettävyys akuutissa aivoinfarktissa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The trial population consists of patients of both sexes, aged ≥18 years, with acute ischaemic stroke and a score on the NIHSS of 6 up to and including 18 at screening [Assessment 1, within 90 minutes before the start of the treatment phase TP].
     Written informed consent obtained from the patient or his/her legally acceptable representative or under such other arrangements as may be legally established in participating countries.
     Estimated body weight of 50kg up to and including 120kg.
     Possibility to start therapeutic hypothermia within 6 hours after onset of stroke.
     Possibility to start therapeutic hypothermia within 90 minutes after start of alteplase administration in patients receiving thrombolysis at the trial site.
     Possibility to start therapeutic hypothermia within 90 minutes after admission to trial site in patients not receiving thrombolysis or in patients who have received thrombolysis at a different site.
     mRS score ≤2 prior to onset of stroke.
     GCS motor response subscale score ≥5.
    18 vuotta täyttäneitä potilaita, kumpaakin sukupuolta, joilla diagnosoitu akuutti aivoinfarkti (NIHSS 6-18)
    -Tietoon perustuva suostumus on saatu tutkittavalta tai hänen läheiseltään.
    -Tutkittavan paino 50-120 kg
    -tutkimushoito voidaan aloittaa 6 tunnin kuluessa aivoinfarktin alkuoireista.
    -Tukimushoito on mahdollista aloittaa 90 min kuluessa mahdollisen aivoinfarktin liuotushoidon alusta.
    -Tutkimushoito on mahdollista aloittaa 90 min kuluessa sairaalan sapumisesta niillä potilailla jotka eivät saa liuotushoitoa
    -mRS pistemäärä enintään 2 pistettä
    E.4Principal exclusion criteria
    1. Use of monoaminoxidase inhibitors in the 14 days prior to screening.
    2. Current use of medication interacting with pethidine or buspirone.
    3. Acute alcohol intoxication.
    4. Opioid addiction.
    5. Nursing mother or pregnant woman, as verified by a positive urine pregnancy test in females of childbearing potential.
    6. Known hypersensitivity to the IMPs or any of their formulation ingredients.
    7. Patient who is imprisoned or is lawfully kept in an institution.
    8. Employee or direct relative of an employee of the CRO (if applicable), the department of the investigator, or the sponsor.
    9. Participation in an interventional clinical trial within the last 4 weeks, or be under the exclusion period from another trial.
    10. Prior participation in this trial.
    11. Any acutely life-threatening conditions other than acute ischaemic stroke.
    12. Rapidly resolving stroke symptoms.
    13. Evidence from CT or MRI of intracranial haemorrhage or tumour or encephalitis or any diagnosis likely to cause the present symptoms other than acute ischaemic stroke.
    14. Known convulsive disorder, acute closed angle glaucoma, myasthenia gravis.
    15. SPO2 <94% (as measured by pulse oximetry) under nasal oxygen administration.
    16. Other severe respiratory disorder.
    17. Bradycardia (<40 bpm).
    18. Severe cardiac failure, defined as NYHA classification ≥III.
    19. Myocardial infarction or angina pectoris in the 3 months prior to screening.
    20. Vasospastic disorders.
    21. Haematological dyscrasia (e.g., sickle cell disease, cryoglobulinaemia).
    22. Known platelet count <100,000/mm3.
    23. Known INR >1.7.
    24. Skin damage at the sites intended to be used for cooling.
    25. Clinical diagnosis of sepsis.
    26. Known severe hepatic impairment (serum ALAT and/or ASAT >3 times ULN).
    27. Known renal impairment (serum creatinine >2mg/100ml).
    28. Addison’s disease.
    29. Any other condition that may interfere with, or be aggravated by, therapeutic hypothermia.
    30. Any condition that is thought to reduce the compliance to cooperate with the trial procedures .
    ks. englanninkieliset
    E.5 End points
    E.5.1Primary end point(s)
    Score on the mRS.
    mRS pistemäärä.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At outcome assessment [A7, Day 90±14 days].
    Päivä 90±14 päivää
    E.5.2Secondary end point(s)
     Death or dependency, defined as a score on the mRS >2.
     Death.
     Score on NIHSS.
     Brain infarct size.
     WHODAS 2.0 score.
     EQ-5D-5L score.
     Kuolema tai ei-omatoiminen toipuminen mRS >2.
     Kuolema.
     NIHSS pistemäärä.
     Aivoinfarktin koko
     WHODAS 2.0-pisteet.
     EQ-5D-5L-pisteet.
    E.5.2.1Timepoint(s) of evaluation of this end point
     Death or dependency, defined as a score on the mRS >2 at outcome assessment [A7, Day 91±14 days].
     Death at outcome assessment [A7, Day 91±14 days].
     Score on NIHSS at outcome assessment [A7, Day 91±14 days].
     Brain infarct size at imaging assessment [A4, Hour 48±24 hours].
     WHODAS 2.0 score at outcome assessment [A7, Day 91±14 days].
     EQ-5D-5L score at outcome assessment [A7, Day 91±14 days].
    ks. englanninkielinen
    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 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) Yes
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standardihoito
    Best medical treatment.
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Yes
    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.
    viimeisen potilaan viimeinen käynti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 Yes
    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
    If patient is unable to reach a balaced view of the potential risk and benefits of participation his/her legally acceptable representative can give a consent.
    Jos tutkittava ei voi antaa tietoista suostumusta, pyydetään suostumus hänen omaiseltaan.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 1500
    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)
    Standard therapy.
    Standardihoito
    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 EuroHYP - European Stroke Research Network for Hypothermia
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-02
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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